{
    "info": {
        "nct_id": "NCT04248582",
        "official_title": "Phase 1 Dose-Frequency Escalation Study of Neoadjuvant Cryotherapy in Locally Advanced Esophageal Cancer",
        "inclusion_criteria": "Adult patients with locally advanced esophageal cancer will be eligible to participate in the study. Eligible patients must have a histologically proven diagnosis of esophageal adenocarcinoma, esophageal squamous cell carcinoma, adenosquamous carcinoma, or gastro-esophageal junctional adenocarcinoma. Locally advanced esophageal cancer will be defined as absence of distant metastases on positron emission tomography-computed tomography (PET-CT) and a TNM stage of IIA to IIIC, as defined by endoscopic ultrasound and PET-CT\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Pediatric patients (age less than 18 years)\n2. Superficial esophageal cancer\n3. Inability to pass the orogastric decompression tube into the stomach\n4. Coagulopathy (INR > 2 or platelet count < 50,000/cubic millimeter).\n5. Inability to provide informed consent\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≥3\n7. Pregnancy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Adult patients with locally advanced esophageal cancer will be eligible to participate in the study. Eligible patients must have a histologically proven diagnosis of esophageal adenocarcinoma, esophageal squamous cell carcinoma, adenosquamous carcinoma, or gastro-esophageal junctional adenocarcinoma. Locally advanced esophageal cancer will be defined as absence of distant metastases on positron emission tomography-computed tomography (PET-CT) and a TNM stage of IIA to IIIC, as defined by endoscopic ultrasound and PET-CT",
            "criterions": [
                {
                    "exact_snippets": "Adult patients",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced esophageal cancer",
                    "criterion": "esophageal cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically proven diagnosis of esophageal adenocarcinoma, esophageal squamous cell carcinoma, adenosquamous carcinoma, or gastro-esophageal junctional adenocarcinoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "esophageal adenocarcinoma",
                                "esophageal squamous cell carcinoma",
                                "adenosquamous carcinoma",
                                "gastro-esophageal junctional adenocarcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of distant metastases on positron emission tomography-computed tomography (PET-CT)",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM stage of IIA to IIIC, as defined by endoscopic ultrasound and PET-CT",
                    "criterion": "TNM stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2.1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3.3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Pediatric patients (age less than 18 years)",
            "criterions": [
                {
                    "exact_snippets": "Pediatric patients (age less than 18 years)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Superficial esophageal cancer",
            "criterions": [
                {
                    "exact_snippets": "Superficial esophageal cancer",
                    "criterion": "esophageal cancer",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "superficial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Inability to pass the orogastric decompression tube into the stomach",
            "criterions": [
                {
                    "exact_snippets": "Inability to pass the orogastric decompression tube into the stomach",
                    "criterion": "orogastric decompression tube passage",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Coagulopathy (INR > 2 or platelet count < 50,000/cubic millimeter).",
            "criterions": [
                {
                    "exact_snippets": "Coagulopathy (INR > 2",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count < 50,000/cubic millimeter",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": "cubic millimeter"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Inability to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Inability to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group (ECOG) performance status ≥3",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≥3",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}