{
"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": [
{
"identified_line": {
"line": "* Must be willing and able to provide fecal samples according to protocol schedule",
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{
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{
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"requirement": {
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},
"logical_structure": {
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{
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},
{
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"requirement": {
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"expected_value": true
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{
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"criterion": "metastatic colorectal cancer",
"requirement": {
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"expected_value": true
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},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy",
"criterion": "chemotherapy regimen",
"requirement": {
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{
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}
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"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy",
"criterion": "chemotherapy regimen",
"requirement": {
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{
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}
]
}
},
{
"identified_line": {
"line": "* Must have radiologic evidence of disease",
"criterions": [
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{
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"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "metastatic cancer",
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}
}
]
}
},
{
"identified_line": {
"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": [
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"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",
"requirement": {
"requirement_type": "treatment type",
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}
},
{
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},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
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"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",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "single agent therapy"
}
},
{
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{
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{
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"criterions": [
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"expected_value": true
}
}
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},
"logical_structure": {
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}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
]
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"logical_structure": {
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}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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"criterion": "age",
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"value": 18,
"unit": "Years"
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{
"identified_line": {
"line": "* COHORT A",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* COHORT B",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"exclusion_lines": [
{
"identified_line": {
"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": [
{
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"criterion": "colostomy",
"requirement": {
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"expected_value": false
}
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{
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"criterion": "issues preventing stool collection",
"requirement": {
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"expected_value": false
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}
]
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}