{
"info": {
"nct_id": "NCT05958082",
"official_title": "Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients with High-Risk Prostate Cancer",
"inclusion_criteria": "1. Men, age greater than or equal to 18 years of age.\n2. Men who racially identify as black or multiracial including black\n3. Diagnosis of prostate cancer of any histology.\n4. Must meet NCCN guidelines for germline testing\n\n 1. Men with very low, low or intermediate risk prostate per NCCN guidelines with a positive family history or intraductal histology. Family history here is considered significant if the patient has:\n\n * a first degree relative with prostate cancer or more than one first/second degree relative with prostate cancer, or\n * ≥3 cancers on same side of family, especially diagnoses ≤50 years of age: bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (but not clinically localized Grade Group 1), small bowel, or urothelial cancer\n 2. Men with high-risk, very-high risk (per NCCN definitions of risk groups), lymph node positive, or metastatic prostate cancer independent of family history of histology.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Have had prior germline testing.\n2. Have somatic genetic testing that is positive for a possible germline variant.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Men, age greater than or equal to 18 years of age.",
"criterions": [
{
"exact_snippets": "Men",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"exact_snippets": "age greater than or equal to 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Men",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"exact_snippets": "age greater than or equal to 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Men who racially identify as black or multiracial including black",
"criterions": [
{
"exact_snippets": "Men",
"criterion": "gender",
"requirement": {
"requirement_type": "identity",
"expected_value": "male"
}
},
{
"exact_snippets": "racially identify as black or multiracial including black",
"criterion": "racial identity",
"requirement": {
"requirement_type": "identity",
"expected_value": [
"black",
"multiracial including black"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Men",
"criterion": "gender",
"requirement": {
"requirement_type": "identity",
"expected_value": "male"
}
},
{
"exact_snippets": "racially identify as black or multiracial including black",
"criterion": "racial identity",
"requirement": {
"requirement_type": "identity",
"expected_value": [
"black",
"multiracial including black"
]
}
}
]
}
},
{
"identified_line": {
"line": "3. Diagnosis of prostate cancer of any histology.",
"criterions": [
{
"exact_snippets": "Diagnosis of prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "any histology",
"criterion": "histology",
"requirement": {
"requirement_type": "type",
"expected_value": "any"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis of prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "any histology",
"criterion": "histology",
"requirement": {
"requirement_type": "type",
"expected_value": "any"
}
}
]
}
},
{
"identified_line": {
"line": "4. Must meet NCCN guidelines for germline testing",
"criterions": [
{
"exact_snippets": "Must meet NCCN guidelines for germline testing",
"criterion": "NCCN guidelines for germline testing",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must meet NCCN guidelines for germline testing",
"criterion": "NCCN guidelines for germline testing",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "1. Men with very low, low or intermediate risk prostate per NCCN guidelines with a positive family history or intraductal histology. Family history here is considered significant if the patient has:",
"criterions": [
{
"exact_snippets": "Men with very low, low or intermediate risk prostate per NCCN guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"very low",
"low",
"intermediate"
]
}
},
{
"exact_snippets": "positive family history",
"criterion": "family history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "intraductal histology",
"criterion": "intraductal histology",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Men with very low, low or intermediate risk prostate per NCCN guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"very low",
"low",
"intermediate"
]
}
},
{
"or_criteria": [
{
"exact_snippets": "positive family history",
"criterion": "family history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "intraductal histology",
"criterion": "intraductal histology",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* a first degree relative with prostate cancer or more than one first/second degree relative with prostate cancer, or",
"criterions": [
{
"exact_snippets": "a first degree relative with prostate cancer",
"criterion": "first degree relative with prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "more than one first/second degree relative with prostate cancer",
"criterion": "first/second degree relatives with prostate cancer",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "relatives"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "a first degree relative with prostate cancer",
"criterion": "first degree relative with prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "more than one first/second degree relative with prostate cancer",
"criterion": "first/second degree relatives with prostate cancer",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "relatives"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Men with high-risk, very-high risk (per NCCN definitions of risk groups), lymph node positive, or metastatic prostate cancer independent of family history of histology.",
"criterions": [
{
"exact_snippets": "Men",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"exact_snippets": "high-risk, very-high risk (per NCCN definitions of risk groups)",
"criterion": "prostate cancer risk group",
"requirement": {
"requirement_type": "risk level",
"expected_value": [
"high-risk",
"very-high risk"
]
}
},
{
"exact_snippets": "lymph node positive",
"criterion": "lymph node status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "metastatic prostate cancer",
"criterion": "prostate cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Men",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"or_criteria": [
{
"exact_snippets": "high-risk, very-high risk (per NCCN definitions of risk groups)",
"criterion": "prostate cancer risk group",
"requirement": {
"requirement_type": "risk level",
"expected_value": [
"high-risk",
"very-high risk"
]
}
},
{
"exact_snippets": "lymph node positive",
"criterion": "lymph node status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "metastatic prostate cancer",
"criterion": "prostate cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
}
]
}
]
}
},
{
"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 be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
},
{
"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"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Have had prior germline testing.",
"criterions": [
{
"exact_snippets": "Have had prior germline testing.",
"criterion": "germline testing",
"requirement": {
"requirement_type": "prior occurrence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Have had prior germline testing.",
"criterion": "germline testing",
"requirement": {
"requirement_type": "prior occurrence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Have somatic genetic testing that is positive for a possible germline variant.",
"criterions": [
{
"exact_snippets": "somatic genetic testing that is positive for a possible germline variant",
"criterion": "somatic genetic testing",
"requirement": {
"requirement_type": "result",
"expected_value": "positive for a possible germline variant"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "somatic genetic testing that is positive for a possible germline variant",
"criterion": "somatic genetic testing",
"requirement": {
"requirement_type": "result",
"expected_value": "positive for a possible germline variant"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* ≥3 cancers on same side of family, especially diagnoses ≤50 years of age: bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (but not clinically localized Grade Group 1), small bowel, or urothelial cancer",
"criterions": [
{
"exact_snippets": "≥3 cancers on same side of family",
"criterion": "cancers on same side of family",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "N/A"
}
}
},
{
"exact_snippets": "diagnoses ≤50 years of age",
"criterion": "age at diagnosis",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 50,
"unit": "years"
}
}
},
{
"exact_snippets": "bile duct",
"criterion": "bile duct cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "breast",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "colorectal",
"criterion": "colorectal cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "endometrial",
"criterion": "endometrial cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "gastric",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "kidney",
"criterion": "kidney cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "melanoma",
"criterion": "melanoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "ovarian",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pancreatic",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "prostate (but not clinically localized Grade Group 1)",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "prostate (but not clinically localized Grade Group 1)",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "grade group",
"expected_value": "not clinically localized Grade Group 1"
}
},
{
"exact_snippets": "small bowel",
"criterion": "small bowel cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "urothelial cancer",
"criterion": "urothelial cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}