{
    "info": {
        "nct_id": "NCT06513962",
        "official_title": "Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer",
        "inclusion_criteria": "* < 40 years of age at the time of enrollment\n* Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)\n* Newly diagnosed with first cancer, exclusive of breast cancer.\n* Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard.\n* For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED.\n* All patients and/or their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\nHealthy volunteers allowed\nMust be FEMALE\nMust have maximum age of 39 Years",
        "exclusion_criteria": "* Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).\n* Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).\n* Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.\n* Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.\n* Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.\n* Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted prior to study enrollment.\n* Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).\n* Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.\n* Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* < 40 years of age at the time of enrollment",
            "criterions": [
                {
                    "exact_snippets": "< 40 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)",
            "criterions": [
                {
                    "exact_snippets": "Patient must be a post-menarchal female",
                    "criterion": "post-menarchal status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "report that their initial menstrual period occurred > 6 months prior to enrollment",
                    "criterion": "time since initial menstrual period",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Newly diagnosed with first cancer, exclusive of breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed with first cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        },
                        {
                            "requirement_type": "occurrence",
                            "expected_value": "first"
                        }
                    ]
                },
                {
                    "exact_snippets": "exclusive of breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard.",
            "criterions": [
                {
                    "exact_snippets": "Planned treatment must include one or more of the following alkylating agents ... cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard.",
                    "criterion": "alkylating agents in planned treatment",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "cyclophosphamide",
                                "ifosfamide",
                                "procarbazine",
                                "chlorambucil",
                                "carmustine (BCNU)",
                                "lomustine (CCNU)",
                                "melphalan",
                                "thiotepa",
                                "busulfan",
                                "nitrogen mustard"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Planned treatment must include one or more of the following alkylating agents delivered with curative intent",
                    "criterion": "curative intent of treatment",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED.",
            "criterions": [
                {
                    "exact_snippets": "patients < 20 years of age at enrollment",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients ≥ 20 years of age at enrollment",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected alkylator dose must be ≥ 4 g/m^2 cumulative cyclophosphamide equivalent dose (CED)",
                    "criterion": "alkylator dose",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "g/m^2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eligible patients must receive at least one of the alkylators that contribute to CED",
                    "criterion": "alkylator receipt",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients and/or their parents or legal guardians must sign a written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "patients and/or their parents or legal guardians must sign a written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.",
            "criterions": [
                {
                    "exact_snippets": "All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.",
                    "criterion": "institutional requirements for human studies",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.",
                    "criterion": "Food and Drug Administration (FDA) requirements for human studies",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.",
                    "criterion": "National Cancer Institute (NCI) requirements for human studies",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 39 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 39 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 39,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).",
            "criterions": [
                {
                    "exact_snippets": "planned radiation to the pelvis",
                    "criterion": "planned radiation to the pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cranial radiation ≥ 30 gray (Gy) to the hypothalamus",
                    "criterion": "cranial radiation to the hypothalamus",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "gray (Gy)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total body irradiation (TBI)",
                    "criterion": "total body irradiation (TBI)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).",
            "criterions": [
                {
                    "exact_snippets": "Planned bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participant's desire to pursue alternative fertility preservation procedures",
                    "criterion": "desire for alternative fertility preservation procedures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.",
            "criterions": [
                {
                    "exact_snippets": "Congenital syndromes associated with infertility and decreased ovarian reserve",
                    "criterion": "congenital syndromes",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": [
                                "infertility",
                                "decreased ovarian reserve"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Turner's Syndrome",
                    "criterion": "Turner's Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Fragile X premutation carriers",
                    "criterion": "Fragile X premutation carriers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Down syndrome",
                    "criterion": "Down syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pseudotumor cerebri",
                    "criterion": "pseudotumor cerebri",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... venous thrombosis",
                    "criterion": "venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of long acting (depot) GnRH agonists within 6 months before enrollment.",
                    "criterion": "long acting (depot) GnRH agonists",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion",
                    "criterion": "subcutaneous GnRH agonist for oocyte retrieval",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "oral and other hormonal contraceptive use is also not an exclusion",
                    "criterion": "oral and other hormonal contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Prior receipt of systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "steroids ... are permitted prior to study enrollment",
                    "criterion": "steroids",
                    "requirements": [
                        {
                            "requirement_type": "prior receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intrathecal chemotherapy are permitted prior to study enrollment",
                    "criterion": "intrathecal chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).",
            "criterions": [
                {
                    "exact_snippets": "Any prior radiation to the pelvis",
                    "criterion": "prior radiation to the pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cranial radiation ≥ 30 Gy to the hypothalamus",
                    "criterion": "cranial radiation to the hypothalamus",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "Gy"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total body irradiation (TBI)",
                    "criterion": "total body irradiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant are not eligible",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "A pregnancy test is required for female patients of childbearing potential",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).",
            "criterions": [
                {
                    "exact_snippets": "Lactating females",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "lactating"
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to breastfeed their infants",
                    "criterion": "breastfeeding plan",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "duration of triptorelin therapy (24 weeks per dose)",
                    "criterion": "triptorelin therapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "24 weeks per dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).",
            "criterions": [
                {
                    "exact_snippets": "Sexually active patients",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients of reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not agreed to use an effective contraceptive method",
                    "criterion": "contraceptive method agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}