{
"info": {
"nct_id": "NCT05494320",
"official_title": "The Effect of ATP-Binding Cassette C2 (ABCC2) Transporter Genetic Polymorphism on Neurotoxicity in Gastrointestinal Cancer Patients Receiving Oxaliplatin -Based Chemotherapy",
"inclusion_criteria": "1. gastrointestinal cancer Patients ( ≥ stages II ) who receive Oxaliplatin based chemotherapy ( FOLFOX6 ) for adjuvant and metastatic setting.\n2. Eastern Cooperative Oncology Group ( ECOG ) performance ≤ 2.\n3. Adequate bone marrow functions ,liver functions and renal functions.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Patients who have any clinical neuropathy.\n2. Pateints with Diabetes mellitus.\n3. Serious comorbid systemic disorder incompatible with study.\n4. Pregnancy.\n5. Other primary tumors.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. gastrointestinal cancer Patients ( ≥ stages II ) who receive Oxaliplatin based chemotherapy ( FOLFOX6 ) for adjuvant and metastatic setting.",
"criterions": [
{
"exact_snippets": "gastrointestinal cancer Patients",
"criterion": "gastrointestinal cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "( ≥ stages II )",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
},
{
"exact_snippets": "receive Oxaliplatin based chemotherapy ( FOLFOX6 )",
"criterion": "chemotherapy regimen",
"requirement": {
"requirement_type": "type",
"expected_value": "Oxaliplatin based chemotherapy ( FOLFOX6 )"
}
},
{
"exact_snippets": "adjuvant and metastatic setting",
"criterion": "treatment setting",
"requirement": {
"requirement_type": "type",
"expected_value": [
"adjuvant",
"metastatic"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "gastrointestinal cancer Patients",
"criterion": "gastrointestinal cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "( ≥ stages II )",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
},
{
"exact_snippets": "receive Oxaliplatin based chemotherapy ( FOLFOX6 )",
"criterion": "chemotherapy regimen",
"requirement": {
"requirement_type": "type",
"expected_value": "Oxaliplatin based chemotherapy ( FOLFOX6 )"
}
},
{
"exact_snippets": "adjuvant and metastatic setting",
"criterion": "treatment setting",
"requirement": {
"requirement_type": "type",
"expected_value": [
"adjuvant",
"metastatic"
]
}
}
]
}
},
{
"identified_line": {
"line": "2. Eastern Cooperative Oncology Group ( ECOG ) performance ≤ 2.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group ( ECOG ) performance ≤ 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "performance status",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group ( ECOG ) performance ≤ 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "performance status",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Adequate bone marrow functions ,liver functions and renal functions.",
"criterions": [
{
"exact_snippets": "Adequate bone marrow functions",
"criterion": "bone marrow functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "adequate ... liver functions",
"criterion": "liver functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "adequate ... renal functions",
"criterion": "renal functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate bone marrow functions",
"criterion": "bone marrow functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "adequate ... liver functions",
"criterion": "liver functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "adequate ... renal functions",
"criterion": "renal functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Patients who have any clinical neuropathy.",
"criterions": [
{
"exact_snippets": "Patients who have any clinical neuropathy",
"criterion": "clinical neuropathy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who have any clinical neuropathy",
"criterion": "clinical neuropathy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Pateints with Diabetes mellitus.",
"criterions": [
{
"exact_snippets": "Diabetes mellitus",
"criterion": "Diabetes mellitus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diabetes mellitus",
"criterion": "Diabetes mellitus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Serious comorbid systemic disorder incompatible with study.",
"criterions": [
{
"exact_snippets": "Serious comorbid systemic disorder incompatible with study.",
"criterion": "comorbid systemic disorder",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "Serious comorbid systemic disorder incompatible with study.",
"criterion": "comorbid systemic disorder",
"requirement": {
"requirement_type": "compatibility with study",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Serious comorbid systemic disorder incompatible with study.",
"criterion": "comorbid systemic disorder",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "Serious comorbid systemic disorder incompatible with study.",
"criterion": "comorbid systemic disorder",
"requirement": {
"requirement_type": "compatibility with study",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "4. Pregnancy.",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "5. Other primary tumors.",
"criterions": [
{
"exact_snippets": "Other primary tumors.",
"criterion": "primary tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Other primary tumors.",
"criterion": "primary tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}