{
    "info": {
        "nct_id": "NCT05644431",
        "official_title": "A Prospective Clinicobiological Cohort Study Aiming to Decipher Tumor Immune Microenvironment Evolution Under Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junctional Adenocarcinomas",
        "inclusion_criteria": "* Male or female patient > 18 years of age on day of signing informed consent.\n* Histologically proven non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, Stage IB to III to be treated with standard neoadjuvant treatment.\n* Surgery of primary tumor to be done at Centre Léon Bérard.\n* Availability of archival FFPE tumor block from initial diagnosis with at least 20% of tumor cells.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.\n* Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n* Patients must be covered by a medical insurance.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Any condition contraindicated with blood sampling procedures required by the protocol.\n* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer\n* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n* Pregnant or breast-feeding woman.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female patient > 18 years of age on day of signing informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Male or female patient",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patient > 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically proven non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, Stage IB to III to be treated with standard neoadjuvant treatment.",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven",
                    "criterion": "histological proof",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-metastatic",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "resectable",
                    "criterion": "resectability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric and gastroesophageal junction adenocarcinoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gastric adenocarcinoma",
                                "gastroesophageal junction adenocarcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IB to III",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.1,
                                        "unit": "Stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "Stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "to be treated with standard neoadjuvant treatment",
                    "criterion": "treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "planned treatment",
                            "expected_value": "standard neoadjuvant treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgery of primary tumor to be done at Centre Léon Bérard.",
            "criterions": [
                {
                    "exact_snippets": "Surgery of primary tumor to be done at Centre Léon Bérard.",
                    "criterion": "surgery location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "Centre Léon Bérard"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Availability of archival FFPE tumor block from initial diagnosis with at least 20% of tumor cells.",
            "criterions": [
                {
                    "exact_snippets": "Availability of archival FFPE tumor block",
                    "criterion": "archival FFPE tumor block",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 20% of tumor cells",
                    "criterion": "tumor cell percentage",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Patient should understand, sign, and date the written voluntary informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "date",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient should be able and willing to comply with study visits and procedures",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be covered by a medical insurance.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be covered by a medical insurance.",
                    "criterion": "medical insurance coverage",
                    "requirements": [
                        {
                            "requirement_type": "coverage",
                            "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": "* Any condition contraindicated with blood sampling procedures required by the protocol.",
            "criterions": [
                {
                    "exact_snippets": "condition contraindicated with blood sampling procedures",
                    "criterion": "condition contraindicated with blood sampling",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "Known additional malignancy that is progressing or requires active treatment.",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "active treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... squamous cell carcinoma of the skin",
                    "criterion": "squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.",
            "criterions": [
                {
                    "exact_snippets": "psychological, familial, geographic or social situation",
                    "criterion": "situation",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "psychological",
                                "familial",
                                "geographic",
                                "social"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "provision of informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "compliance to study procedure",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding woman.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}