{
    "info": {
        "nct_id": "NCT04972682",
        "official_title": "Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial",
        "inclusion_criteria": "* Age ≥18 years\n* Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)\n* FIGO stage IA\n* FIGO stage IB and II when LND is contraindicated\n* No contraindications for surgery\n* Signed informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* • Age <18 years\n* Presence of tumor spread outside the corpus uteri\n* Absence of tumor invasion into the myometrium\n* High-grade tumor (G3)\n* Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)\n* Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy\n* Prior pelvic or retroperitoneal LND\n* History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization\n* Allergy to iodine-containing drugs\n* Contraindications to surgical treatment\n* Lack of signed informed consent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)",
            "criterions": [
                {
                    "exact_snippets": "Histologically verified",
                    "criterion": "histological verification",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "low-grade endometrioid adenocarcinoma of the endometrium",
                    "criterion": "endometrioid adenocarcinoma of the endometrium",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "low-grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "(G1-G2)",
                    "criterion": "tumor grade",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "G"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "G"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FIGO stage IA",
            "criterions": [
                {
                    "exact_snippets": "FIGO stage IA",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IA"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FIGO stage IB and II when LND is contraindicated",
            "criterions": [
                {
                    "exact_snippets": "FIGO stage IB and II",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IB",
                                "II"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "LND is contraindicated",
                    "criterion": "LND contraindication",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No contraindications for surgery",
            "criterions": [
                {
                    "exact_snippets": "No contraindications for surgery",
                    "criterion": "contraindications for surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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 minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* • Age <18 years",
            "criterions": [
                {
                    "exact_snippets": "Age <18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of tumor spread outside the corpus uteri",
            "criterions": [
                {
                    "exact_snippets": "Presence of tumor spread outside the corpus uteri",
                    "criterion": "tumor spread outside the corpus uteri",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of tumor invasion into the myometrium",
            "criterions": [
                {
                    "exact_snippets": "Absence of tumor invasion into the myometrium",
                    "criterion": "tumor invasion into the myometrium",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High-grade tumor (G3)",
            "criterions": [
                {
                    "exact_snippets": "High-grade tumor (G3)",
                    "criterion": "tumor grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "G3"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)",
            "criterions": [
                {
                    "exact_snippets": "Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)",
                    "criterion": "Bokhman type 2 tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy",
            "criterions": [
                {
                    "exact_snippets": "Preoperative treatment of endometrial cancer including radiotherapy",
                    "criterion": "preoperative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative treatment of endometrial cancer including ... systemic chemotherapy",
                    "criterion": "preoperative systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative treatment of endometrial cancer including ... hormone therapy",
                    "criterion": "preoperative hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior pelvic or retroperitoneal LND",
            "criterions": [
                {
                    "exact_snippets": "Prior pelvic or retroperitoneal LND",
                    "criterion": "pelvic or retroperitoneal lymph node dissection (LND)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization",
            "criterions": [
                {
                    "exact_snippets": "History of surgeries on the uterus and uterine appendages",
                    "criterion": "surgeries on the uterus and uterine appendages",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions such as cesarean section",
                    "criterion": "cesarean section",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions such as ... tubectomy",
                    "criterion": "tubectomy",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions such as ... oophorectomy",
                    "criterion": "oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions such as ... ovarian resection",
                    "criterion": "ovarian resection",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions such as ... ovarian biopsy",
                    "criterion": "ovarian biopsy",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions such as ... ovarian cauterization",
                    "criterion": "ovarian cauterization",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergy to iodine-containing drugs",
            "criterions": [
                {
                    "exact_snippets": "Allergy to iodine-containing drugs",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "iodine-containing drugs"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindications to surgical treatment",
            "criterions": [
                {
                    "exact_snippets": "Contraindications to surgical treatment",
                    "criterion": "surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Lack of signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}