{
    "info": {
        "nct_id": "NCT01775072",
        "official_title": "Genomic Profiling in Cancer Patients",
        "inclusion_criteria": "Part A:\n\n* Patients with a history of cancer or patients without a documented cancer history undergoing a surgical procedure, endoscopy, biopsy, or liquid biopsy (for example cell free DNA testing) to confirm or exclude a cancer diagnosis, or\n* Any participant having a test or procedure that has the potential to provide a specimen that can be banked for future research purposes, or\n* Any participant who has already had a diagnostic or therapeutic procedure that has yielded tissue, blood or other bodily fluids presently in the archive but who has not yet been approached to participate is also eligible.\n\nPart B:\n\n* Patients must be successfully registered to Part A of MSKCC IRB# 12-245\n* Prior written approval for patient consent obtained from the Principal/Co-Principal Investigator of MSKCC IRB # 12-245.\n\nPart C:\n\n* Patient must be receiving ongoing care at MSK or a CHERPn/ Alliance/Affiliate site or have previously consulted with an MSK physician.\n* Patient must have successfully consented to Part A of this study.\n\nPart D:\n\n* Patients with no personal cancer history at increased risk for cancer development due to family history, molecular cancer marker, know carrier status of a gene associated with increased cancer risk or prior/ongoing environmental exposures or lifestyle factors.\nHealthy volunteers allowed",
        "exclusion_criteria": "All Parts:\n\n* Unwilling or unable to provide informed consent.\n\nPart C:\n\n* All patients consenting to Part A are eligible to consent to 12-245, Part C. Most patients will be eligible to receive clinical germline testing with return of results to the patient/health care providers. However, several exclusion criteria apply and are outlined below\n\n  1. Solid tumor patients: Secondary germline analysis using BAM files generated for MSK-IMPACT testing is not an option for patients with solid tumors and an acute or chronic hematologic neoplasm that would preclude the use of blood or saliva as a source of germline DNA. Such patient may be eligible for primary germline testing using a non-blood source of germline DNA as per standard clinical guidelines. Solid tumor patients who have had an allogenic bone marrow/stem cell transplant will only be considered eligible for germline testing under Part C if a sample adequate for germline testing had previously been collected prior to allogenic bone marrow/stem cell transplant.\n  2. Hematologic cancer patients: For patients with a hematopoietic neoplasm, germline testing may be an option under Part C using nail clippings or another non-blood source of DNA as per standard clinical practice. For patients who have had an allogenic bone marrow/stem cell transplant, clinical germline testing will only be considered under Part C if a sample adequate for germline testing had previously been collected prior to Allogenic bone marrow/stem cell transplant.\n\nPart D\n\n* Exclusion criteria are same as those for Part C outlined above.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Part A:",
            "criterions": [
                {
                    "exact_snippets": "Part A",
                    "criterion": "trial part",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": "A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of cancer or patients without a documented cancer history undergoing a surgical procedure, endoscopy, biopsy, or liquid biopsy (for example cell free DNA testing) to confirm or exclude a cancer diagnosis, or",
            "criterions": [
                {
                    "exact_snippets": "history of cancer",
                    "criterion": "cancer history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without a documented cancer history",
                    "criterion": "cancer history",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing a surgical procedure",
                    "criterion": "surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "endoscopy",
                    "criterion": "endoscopy",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy",
                    "criterion": "biopsy",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "liquid biopsy (for example cell free DNA testing)",
                    "criterion": "liquid biopsy",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any participant having a test or procedure that has the potential to provide a specimen that can be banked for future research purposes, or",
            "criterions": [
                {
                    "exact_snippets": "having a test or procedure that has the potential to provide a specimen that can be banked for future research purposes",
                    "criterion": "test or procedure",
                    "requirements": [
                        {
                            "requirement_type": "potential to provide specimen",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any participant who has already had a diagnostic or therapeutic procedure that has yielded tissue, blood or other bodily fluids presently in the archive but who has not yet been approached to participate is also eligible.",
            "criterions": [
                {
                    "exact_snippets": "diagnostic or therapeutic procedure that has yielded tissue, blood or other bodily fluids presently in the archive",
                    "criterion": "archived biological samples",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has not yet been approached to participate",
                    "criterion": "approach to participate",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not yet approached"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be successfully registered to Part A of MSKCC IRB# 12-245",
            "criterions": [
                {
                    "exact_snippets": "successfully registered to Part A of MSKCC IRB# 12-245",
                    "criterion": "registration to Part A of MSKCC IRB# 12-245",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "successfully registered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior written approval for patient consent obtained from the Principal/Co-Principal Investigator of MSKCC IRB # 12-245.",
            "criterions": [
                {
                    "exact_snippets": "Prior written approval for patient consent obtained from the Principal/Co-Principal Investigator of MSKCC IRB # 12-245.",
                    "criterion": "written approval for patient consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be receiving ongoing care at MSK or a CHERPn/ Alliance/Affiliate site or have previously consulted with an MSK physician.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be receiving ongoing care at MSK or a CHERPn/ Alliance/Affiliate site",
                    "criterion": "ongoing care location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "MSK",
                                "CHERPn/ Alliance/Affiliate site"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "or have previously consulted with an MSK physician",
                    "criterion": "previous consultation with MSK physician",
                    "requirements": [
                        {
                            "requirement_type": "consultation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have successfully consented to Part A of this study.",
            "criterions": [
                {
                    "exact_snippets": "Patient must have successfully consented to Part A of this study.",
                    "criterion": "consent to Part A of this study",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "successfully consented"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with no personal cancer history at increased risk for cancer development due to family history, molecular cancer marker, know carrier status of a gene associated with increased cancer risk or prior/ongoing environmental exposures or lifestyle factors.",
            "criterions": [
                {
                    "exact_snippets": "no personal cancer history",
                    "criterion": "personal cancer history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "increased risk for cancer development due to family history",
                    "criterion": "family history",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    ]
                },
                {
                    "exact_snippets": "increased risk for cancer development due to ... molecular cancer marker",
                    "criterion": "molecular cancer marker",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    ]
                },
                {
                    "exact_snippets": "increased risk for cancer development due to ... know carrier status of a gene associated with increased cancer risk",
                    "criterion": "carrier status of a gene associated with increased cancer risk",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    ]
                },
                {
                    "exact_snippets": "increased risk for cancer development due to ... prior/ongoing environmental exposures",
                    "criterion": "environmental exposures",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    ]
                },
                {
                    "exact_snippets": "increased risk for cancer development due to ... lifestyle factors",
                    "criterion": "lifestyle factors",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "All Parts:",
            "criterions": [
                {
                    "exact_snippets": "All Parts",
                    "criterion": "parts",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unwilling or unable to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Unwilling ... to provide informed consent.",
                    "criterion": "willingness to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to provide informed consent.",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients consenting to Part A are eligible to consent to 12-245, Part C. Most patients will be eligible to receive clinical germline testing with return of results to the patient/health care providers. However, several exclusion criteria apply and are outlined below",
            "criterions": [
                {
                    "exact_snippets": "All patients consenting to Part A",
                    "criterion": "consent to Part A",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible to consent to 12-245, Part C",
                    "criterion": "eligibility to consent to 12-245, Part C",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible to receive clinical germline testing",
                    "criterion": "eligibility for clinical germline testing",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Solid tumor patients: Secondary germline analysis using BAM files generated for MSK-IMPACT testing is not an option for patients with solid tumors and an acute or chronic hematologic neoplasm that would preclude the use of blood or saliva as a source of germline DNA. Such patient may be eligible for primary germline testing using a non-blood source of germline DNA as per standard clinical guidelines. Solid tumor patients who have had an allogenic bone marrow/stem cell transplant will only be considered eligible for germline testing under Part C if a sample adequate for germline testing had previously been collected prior to allogenic bone marrow/stem cell transplant.",
            "criterions": [
                {
                    "exact_snippets": "solid tumors and an acute or chronic hematologic neoplasm",
                    "criterion": "acute or chronic hematologic neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Solid tumor patients who have had an allogenic bone marrow/stem cell transplant",
                    "criterion": "allogenic bone marrow/stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Hematologic cancer patients: For patients with a hematopoietic neoplasm, germline testing may be an option under Part C using nail clippings or another non-blood source of DNA as per standard clinical practice. For patients who have had an allogenic bone marrow/stem cell transplant, clinical germline testing will only be considered under Part C if a sample adequate for germline testing had previously been collected prior to Allogenic bone marrow/stem cell transplant.",
            "criterions": [
                {
                    "exact_snippets": "patients with a hematopoietic neoplasm",
                    "criterion": "hematopoietic neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have had an allogenic bone marrow/stem cell transplant",
                    "criterion": "allogenic bone marrow/stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a sample adequate for germline testing had previously been collected prior to Allogenic bone marrow/stem cell transplant",
                    "criterion": "germline testing sample collection",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to Allogenic bone marrow/stem cell transplant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Part D",
            "criterions": [
                {
                    "exact_snippets": "Part D",
                    "criterion": "trial part",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": "D"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Part B:",
            "criterions": []
        },
        {
            "line": "Part C:",
            "criterions": []
        },
        {
            "line": "Part D:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "Part C:",
            "criterions": []
        },
        {
            "line": "* Exclusion criteria are same as those for Part C outlined above.",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}