{
"info": {
"nct_id": "NCT05746182",
"official_title": "Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms",
"inclusion_criteria": "1. Histologically confirmed PanNEN.\n\n a. The diagnostic biopsy may have been taken from any site (primary or metastatic).\n2. New and existing PanNEN participants will be eligible (any grade, any stage, any age > 18 years).\n3. Participants willing and able to comply with the study procedures.\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Inability to provide informed consent.\n2. For participants who have not had prior testing with a dedicated germline pane of at least 80 genes:\n\n 1. Inability to speak/read a language supported by the germline testing station (GTS). The supported languages currently include English, Korean, Japanese, Vietnamese, Russian, Tagalog, Farsi, Spanish, Cantonese, Mandarin, and Arabic).\n 2. Active hematologic malignancy.\n 3. History of allogenic bone marrow transplant or stem cell transplant.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Histologically confirmed PanNEN.",
"criterions": [
{
"exact_snippets": "Histologically confirmed PanNEN",
"criterion": "PanNEN",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically confirmed PanNEN",
"criterion": "PanNEN",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
}
]
}
},
{
"identified_line": {
"line": "a. The diagnostic biopsy may have been taken from any site (primary or metastatic).",
"criterions": [
{
"exact_snippets": "diagnostic biopsy may have been taken from any site (primary or metastatic)",
"criterion": "diagnostic biopsy site",
"requirement": {
"requirement_type": "site",
"expected_value": [
"primary",
"metastatic"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "diagnostic biopsy may have been taken from any site (primary or metastatic)",
"criterion": "diagnostic biopsy site",
"requirement": {
"requirement_type": "site",
"expected_value": [
"primary",
"metastatic"
]
}
}
]
}
},
{
"identified_line": {
"line": "2. New and existing PanNEN participants will be eligible (any grade, any stage, any age > 18 years).",
"criterions": [
{
"exact_snippets": "PanNEN participants",
"criterion": "PanNEN diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "any grade",
"criterion": "PanNEN grade",
"requirement": {
"requirement_type": "grade",
"expected_value": "any"
}
},
{
"exact_snippets": "any stage",
"criterion": "PanNEN stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "any"
}
},
{
"exact_snippets": "any age > 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PanNEN participants",
"criterion": "PanNEN diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "any grade",
"criterion": "PanNEN grade",
"requirement": {
"requirement_type": "grade",
"expected_value": "any"
}
},
{
"exact_snippets": "any stage",
"criterion": "PanNEN stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "any"
}
},
{
"exact_snippets": "any age > 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Participants willing and able to comply with the study procedures.",
"criterions": [
{
"exact_snippets": "Participants willing ... to comply with the study procedures.",
"criterion": "willingness to comply",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Participants ... able to comply with the study procedures.",
"criterion": "ability to comply",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Participants willing ... to comply with the study procedures.",
"criterion": "willingness to comply",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Participants ... able to comply with the study procedures.",
"criterion": "ability to comply",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"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. Inability to provide informed consent.",
"criterions": [
{
"exact_snippets": "Inability to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Inability to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "2. For participants who have not had prior testing with a dedicated germline pane of at least 80 genes:",
"criterions": [
{
"exact_snippets": "prior testing with a dedicated germline pane of at least 80 genes",
"criterion": "prior germline testing",
"requirement": {
"requirement_type": "gene panel size",
"expected_value": {
"operator": ">=",
"value": 80,
"unit": "genes"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "prior testing with a dedicated germline pane of at least 80 genes",
"criterion": "prior germline testing",
"requirement": {
"requirement_type": "gene panel size",
"expected_value": {
"operator": ">=",
"value": 80,
"unit": "genes"
}
}
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "1. Inability to speak/read a language supported by the germline testing station (GTS). The supported languages currently include English, Korean, Japanese, Vietnamese, Russian, Tagalog, Farsi, Spanish, Cantonese, Mandarin, and Arabic).",
"criterions": [
{
"exact_snippets": "Inability to speak/read a language supported by the germline testing station (GTS).",
"criterion": "language ability",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "The supported languages currently include English, Korean, Japanese, Vietnamese, Russian, Tagalog, Farsi, Spanish, Cantonese, Mandarin, and Arabic",
"criterion": "supported languages",
"requirement": {
"requirement_type": "list",
"expected_value": [
"English",
"Korean",
"Japanese",
"Vietnamese",
"Russian",
"Tagalog",
"Farsi",
"Spanish",
"Cantonese",
"Mandarin",
"Arabic"
]
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Inability to speak/read a language supported by the germline testing station (GTS).",
"criterion": "language ability",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "The supported languages currently include English, Korean, Japanese, Vietnamese, Russian, Tagalog, Farsi, Spanish, Cantonese, Mandarin, and Arabic",
"criterion": "supported languages",
"requirement": {
"requirement_type": "list",
"expected_value": [
"English",
"Korean",
"Japanese",
"Vietnamese",
"Russian",
"Tagalog",
"Farsi",
"Spanish",
"Cantonese",
"Mandarin",
"Arabic"
]
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "2. Active hematologic malignancy.",
"criterions": [
{
"exact_snippets": "Active hematologic malignancy",
"criterion": "hematologic malignancy",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Active hematologic malignancy",
"criterion": "hematologic malignancy",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
}
},
{
"identified_line": {
"line": "3. History of allogenic bone marrow transplant or stem cell transplant.",
"criterions": [
{
"exact_snippets": "History of allogenic bone marrow transplant",
"criterion": "allogenic bone marrow transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... stem cell transplant",
"criterion": "stem cell transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of allogenic bone marrow transplant",
"criterion": "allogenic bone marrow transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... stem cell transplant",
"criterion": "stem cell transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}