{
    "info": {
        "nct_id": "NCT02960282",
        "official_title": "The Role of Microbiome in Cancer Therapy",
        "inclusion_criteria": "* Must be willing and able to provide fecal samples according to protocol schedule\n* COHORT A\n* Diagnosis of metastatic colorectal cancer, where the metastatic disease has not been previously treated\n* Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy for the advanced disease\n* Must have radiologic evidence of disease\n* COHORT B\n* Diagnosis of metastatic cancer\n* Scheduled to begin pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody as single agent therapy for the treatment of the advanced disease\n* Must have physical or radiologic evidence of disease\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with a colostomy or any other issues that may prevent the standard methods for collection of stool are not eligible for this study\n* Patients are not enrolled or a research protocol for treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Must be willing and able to provide fecal samples according to protocol schedule",
            "criterions": [
                {
                    "exact_snippets": "Must be willing and able to provide fecal samples",
                    "criterion": "fecal sample provision",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of metastatic colorectal cancer, where the metastatic disease has not been previously treated",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of metastatic colorectal cancer",
                    "criterion": "metastatic colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease has not been previously treated",
                    "criterion": "treatment history of metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy for the advanced disease",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": [
                                "FOLFOX",
                                "FOLFIRI"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have radiologic evidence of disease",
            "criterions": [
                {
                    "exact_snippets": "Must have radiologic evidence of disease",
                    "criterion": "radiologic evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of metastatic cancer",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of metastatic cancer",
                    "criterion": "metastatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled to begin pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody as single agent therapy for the treatment of the advanced disease",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to begin pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody as single agent therapy",
                    "criterion": "anti-PD-1 or anti-PD-L1 antibody therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "single agent therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "for the treatment of the advanced disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have physical or radiologic evidence of disease",
            "criterions": [
                {
                    "exact_snippets": "physical or radiologic evidence of disease",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 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": "* Patients with a colostomy or any other issues that may prevent the standard methods for collection of stool are not eligible for this study",
            "criterions": [
                {
                    "exact_snippets": "Patients with a colostomy",
                    "criterion": "colostomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other issues that may prevent the standard methods for collection of stool",
                    "criterion": "issues preventing stool collection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients are not enrolled or a research protocol for treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients are not enrolled or a research protocol for treatment",
                    "criterion": "enrollment in a research protocol for treatment",
                    "requirements": [
                        {
                            "requirement_type": "enrollment status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* COHORT A",
            "criterions": []
        },
        {
            "line": "* COHORT B",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}