[96a5a0]: / output / allTrials / identified / NCT01726582_identified.json

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{
"info": {
"nct_id": "NCT01726582",
"official_title": "A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "Any patient with one or more of the following will be excluded:\n\n* Have received chemotherapy or chemoradiation within 5 years prior of study enrollment\n* Have any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study enrollment\n* Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent\n* Known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection\n* Pregnant or breast-feeding patients or any patient with child-bearing potential not using contraception 4 weeks prior to, during and 4 months after study treatment is discontinued",
"miscellaneous_criteria": "Inclusion criteria:\n\n* 18 years of age or older\n* Able to understand and provide written informed consent\n* Diagnosis of adenocarcinoma of the pancreas or high suspicion of adenocarcinoma of the pancreas based on CT and MRI findings as detailed below by \"Definition of....\"\n\nTreatment Eligibility Criteria:\n\n* Have an Eastern Cooperative Oncology Group performance status less than or equal to 2\n* Have biopsy-proven resectable or borderline resectable adenocarcinoma of the pancreas\n* Have adequate organ and bone marrow function as defined by:\n\n * total leukocytes greater than or equal to 3 x1000/μL\n * absolute neutrophil count (ANC) > or equal to 1.5x 1000/μL\n * hemoglobin > or equal to 9 g/dL\n * platelets > or equal to 100 x 1000/μL\n * creatinine clearance >60 mL/min or creatinine < or equal to 1.5 mg/dL\n * bilirubin < or equal to 2 mg/dL or >2 and declining as described in the protocol\n * aspartate transaminases (AST/SGOT) < or equal to3 x upper limit of normal (ULN)\n * alanine transaminases (ALT/SGPT) < or equal to 3 x ULN\n* Female patients must be post menopausal for > 1 year, surgically sterile, or have a negative pregnancy test and used at least one form of contraception for 4 weeks prior to Day 1 of the study, during study treatment and during the first 4 months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for 4 months after the last dose of any study drug.\n\nDefinition of Resectable Pancreatic Cancer includes:\n\n* No evidence of extra-pancreatic disease\n* No evidence of tumor-arterial abutment (celiac, superior mesenteric artery or hepatic artery)\n* If tumor induced narrowing of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence is present it must be <50% of the diameter of the vessel\n* Ca19-9 <5000, when bilirubin is <2 (or >2 and declining as described in the protocol)\n\nDefinition of Borderline Resectable Pancreatic Cancer to include at least one of the following:\n\n* Tumor abutment < or equal to 180 degrees of the superior mesenteric artery or celiac axis\n* Tumor abutment or encasement (>180 degrees) of a short segment of the hepatic artery\n* Tumor induced narrowing of superior mesenteric vein, portal vein or superior mesenteric-portal vein of >50% of the diameter of the vessel.\n* Short segment occlusion of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence with a suitable portal vein above and superior mesenteric vein below, for reconstruction\n* CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on multidisciplinary assessment at the Medical College of Wisconsin weekly pancreatic cancer conference)\n* Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound-guided fine needle aspirate\n* Resectable tumor and cancer antigen 19-9 (CA19-9) >5000"
},
"inclusion_lines": [
{
"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": "Any patient with one or more of the following will be excluded:",
"criterions": [
{
"exact_snippets": "one or more of the following will be excluded",
"criterion": "exclusion criteria",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Have received chemotherapy or chemoradiation within 5 years prior of study enrollment",
"criterions": [
{
"exact_snippets": "Have received chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "recency",
"expected_value": {
"operator": "<",
"value": 5,
"unit": "years"
}
}
]
},
{
"exact_snippets": "Have received ... chemoradiation",
"criterion": "chemoradiation",
"requirements": [
{
"requirement_type": "recency",
"expected_value": {
"operator": "<",
"value": 5,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Have any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study enrollment",
"criterions": [
{
"exact_snippets": "Have any previous history of another malignancy",
"criterion": "previous history of another malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "cured basal or squamous cell carcinoma of the skin",
"criterion": "cured basal or squamous cell carcinoma of the skin",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "cured in-situ carcinoma of the cervix",
"criterion": "cured in-situ carcinoma of the cervix",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "within 5 years of study enrollment",
"criterion": "time since last malignancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent",
"criterions": [
{
"exact_snippets": "Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection",
"criterion": "serious infection",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
},
{
"exact_snippets": "Uncontrolled comorbidities including, but not limited to, ... symptomatic congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "symptomatic",
"expected_value": true
},
{
"requirement_type": "control",
"expected_value": false
}
]
},
{
"exact_snippets": "Uncontrolled comorbidities including, but not limited to, ... unstable angina",
"criterion": "angina",
"requirements": [
{
"requirement_type": "stability",
"expected_value": false
}
]
},
{
"exact_snippets": "Uncontrolled comorbidities including, but not limited to, ... unstable cardiac arrhythmias",
"criterion": "cardiac arrhythmias",
"requirements": [
{
"requirement_type": "stability",
"expected_value": false
}
]
},
{
"exact_snippets": "Uncontrolled comorbidities including, but not limited to, ... psychiatric illness",
"criterion": "psychiatric illness",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
},
{
"exact_snippets": "Uncontrolled comorbidities including, but not limited to, ... excessive obesity",
"criterion": "obesity",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "excessive"
}
]
},
{
"exact_snippets": "Uncontrolled comorbidities including, but not limited to, ... situations that would limit compliance with the study requirements",
"criterion": "compliance with study requirements",
"requirements": [
{
"requirement_type": "limitation",
"expected_value": true
}
]
},
{
"exact_snippets": "Uncontrolled comorbidities including, but not limited to, ... situations that would limit ... the ability to willingly give written informed consent",
"criterion": "ability to give informed consent",
"requirements": [
{
"requirement_type": "limitation",
"expected_value": true
}
]
}
]
},
{
"line": "* Known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection",
"criterions": [
{
"exact_snippets": "Known human immunodeficiency virus",
"criterion": "human immunodeficiency virus infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hepatitis B virus",
"criterion": "hepatitis B virus infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hepatitis C virus infection",
"criterion": "hepatitis C virus infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnant or breast-feeding patients or any patient with child-bearing potential not using contraception 4 weeks prior to, during and 4 months after study treatment is discontinued",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "breast-feeding",
"criterion": "breastfeeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "child-bearing potential",
"criterion": "child-bearing potential",
"requirements": [
{
"requirement_type": "contraception usage",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [
{
"line": "* 18 years of age or older",
"criterions": [
{
"exact_snippets": "18 years of age or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Able to understand and provide written informed consent",
"criterions": [
{
"exact_snippets": "Able to understand",
"criterion": "cognitive ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "provide written informed consent",
"criterion": "consent capability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Diagnosis of adenocarcinoma of the pancreas or high suspicion of adenocarcinoma of the pancreas based on CT and MRI findings as detailed below by \"Definition of....\"",
"criterions": [
{
"exact_snippets": "Diagnosis of adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "high suspicion of adenocarcinoma of the pancreas based on CT and MRI findings",
"criterion": "adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": "high"
},
{
"requirement_type": "imaging",
"expected_value": [
"CT",
"MRI"
]
}
]
}
]
},
{
"line": "* Have an Eastern Cooperative Oncology Group performance status less than or equal to 2",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group performance status less than or equal to 2",
"criterion": "Eastern Cooperative Oncology Group performance status",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Have biopsy-proven resectable or borderline resectable adenocarcinoma of the pancreas",
"criterions": [
{
"exact_snippets": "biopsy-proven",
"criterion": "biopsy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "resectable or borderline resectable",
"criterion": "resectability",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"resectable",
"borderline resectable"
]
}
]
},
{
"exact_snippets": "adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Have adequate organ and bone marrow function as defined by:",
"criterions": [
{
"exact_snippets": "adequate organ and bone marrow function",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "adequate organ and bone marrow function",
"criterion": "bone marrow function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* total leukocytes greater than or equal to 3 x1000/μL",
"criterions": [
{
"exact_snippets": "total leukocytes greater than or equal to 3 x1000/μL",
"criterion": "total leukocytes",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3000,
"unit": "μL"
}
}
]
}
]
},
{
"line": "* absolute neutrophil count (ANC) > or equal to 1.5x 1000/μL",
"criterions": [
{
"exact_snippets": "absolute neutrophil count (ANC) > or equal to 1.5x 1000/μL",
"criterion": "absolute neutrophil count (ANC)",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "μL"
}
}
]
}
]
},
{
"line": "* hemoglobin > or equal to 9 g/dL",
"criterions": [
{
"exact_snippets": "hemoglobin > or equal to 9 g/dL",
"criterion": "hemoglobin level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9,
"unit": "g/dL"
}
}
]
}
]
},
{
"line": "* platelets > or equal to 100 x 1000/μL",
"criterions": [
{
"exact_snippets": "platelets > or equal to 100 x 1000/μL",
"criterion": "platelets",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "μL"
}
}
]
}
]
},
{
"line": "* creatinine clearance >60 mL/min or creatinine < or equal to 1.5 mg/dL",
"criterions": [
{
"exact_snippets": "creatinine clearance >60 mL/min",
"criterion": "creatinine clearance",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "mL/min"
}
}
]
},
{
"exact_snippets": "creatinine < or equal to 1.5 mg/dL",
"criterion": "creatinine",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dL"
}
}
]
}
]
},
{
"line": "* bilirubin < or equal to 2 mg/dL or >2 and declining as described in the protocol",
"criterions": [
{
"exact_snippets": "bilirubin < or equal to 2 mg/dL",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "mg/dL"
}
}
]
},
{
"exact_snippets": "bilirubin ... >2 and declining",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "mg/dL"
}
},
{
"requirement_type": "trend",
"expected_value": "declining"
}
]
}
]
},
{
"line": "* aspartate transaminases (AST/SGOT) < or equal to3 x upper limit of normal (ULN)",
"criterions": [
{
"exact_snippets": "aspartate transaminases (AST/SGOT) < or equal to3 x upper limit of normal (ULN)",
"criterion": "aspartate transaminases (AST/SGOT)",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x ULN"
}
}
]
}
]
},
{
"line": "* alanine transaminases (ALT/SGPT) < or equal to 3 x ULN",
"criterions": [
{
"exact_snippets": "alanine transaminases (ALT/SGPT) < or equal to 3 x ULN",
"criterion": "alanine transaminases (ALT/SGPT)",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x ULN"
}
}
]
}
]
},
{
"line": "* Female patients must be post menopausal for > 1 year, surgically sterile, or have a negative pregnancy test and used at least one form of contraception for 4 weeks prior to Day 1 of the study, during study treatment and during the first 4 months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for 4 months after the last dose of any study drug.",
"criterions": [
{
"exact_snippets": "Female patients must be post menopausal for > 1 year",
"criterion": "menopausal status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "post menopausal"
},
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
]
},
{
"exact_snippets": "Female patients must be ... surgically sterile",
"criterion": "surgical sterility",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "Female patients must ... have a negative pregnancy test",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "Female patients must ... used at least one form of contraception for 4 weeks prior to Day 1 of the study",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "Female patients must ... used at least one form of contraception ... during study treatment",
"criterion": "contraception use during study",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "Female patients must ... used at least one form of contraception ... during the first 4 months after study treatment is discontinued",
"criterion": "contraception use after study",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "months"
}
}
]
},
{
"exact_snippets": "Male patients must be surgically sterile",
"criterion": "surgical sterility",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "Male patients must ... use barrier contraception during the study",
"criterion": "barrier contraception use during study",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "Male patients must ... use barrier contraception ... for 4 months after the last dose of any study drug",
"criterion": "barrier contraception use after study",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "months"
}
}
]
}
]
},
{
"line": "Definition of Resectable Pancreatic Cancer includes:",
"criterions": [
{
"exact_snippets": "Resectable Pancreatic Cancer",
"criterion": "pancreatic cancer",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": true
}
]
}
]
},
{
"line": "* No evidence of extra-pancreatic disease",
"criterions": [
{
"exact_snippets": "No evidence of extra-pancreatic disease",
"criterion": "extra-pancreatic disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No evidence of tumor-arterial abutment (celiac, superior mesenteric artery or hepatic artery)",
"criterions": [
{
"exact_snippets": "No evidence of tumor-arterial abutment (celiac, superior mesenteric artery or hepatic artery)",
"criterion": "tumor-arterial abutment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* If tumor induced narrowing of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence is present it must be <50% of the diameter of the vessel",
"criterions": [
{
"exact_snippets": "tumor induced narrowing of the superior mesenteric vein ... <50% of the diameter of the vessel",
"criterion": "tumor induced narrowing of the superior mesenteric vein",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "% of the diameter of the vessel"
}
}
]
},
{
"exact_snippets": "tumor induced narrowing of the ... portal vein ... <50% of the diameter of the vessel",
"criterion": "tumor induced narrowing of the portal vein",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "% of the diameter of the vessel"
}
}
]
},
{
"exact_snippets": "tumor induced narrowing of the ... superior mesenteric-portal vein confluence ... <50% of the diameter of the vessel",
"criterion": "tumor induced narrowing of the superior mesenteric-portal vein confluence",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "% of the diameter of the vessel"
}
}
]
}
]
},
{
"line": "* Ca19-9 <5000, when bilirubin is <2 (or >2 and declining as described in the protocol)",
"criterions": [
{
"exact_snippets": "Ca19-9 <5000",
"criterion": "Ca19-9 level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 5000,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "bilirubin is <2",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "bilirubin is ... >2 and declining",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "N/A"
}
},
{
"requirement_type": "trend",
"expected_value": "declining"
}
]
}
]
},
{
"line": "Definition of Borderline Resectable Pancreatic Cancer to include at least one of the following:",
"criterions": [
{
"exact_snippets": "Borderline Resectable Pancreatic Cancer",
"criterion": "Borderline Resectable Pancreatic Cancer",
"requirements": [
{
"requirement_type": "definition",
"expected_value": "at least one of the following"
}
]
}
]
},
{
"line": "* Tumor abutment < or equal to 180 degrees of the superior mesenteric artery or celiac axis",
"criterions": [
{
"exact_snippets": "Tumor abutment < or equal to 180 degrees of the superior mesenteric artery or celiac axis",
"criterion": "tumor abutment",
"requirements": [
{
"requirement_type": "angle",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "degrees"
}
}
]
}
]
},
{
"line": "* Tumor abutment or encasement (>180 degrees) of a short segment of the hepatic artery",
"criterions": [
{
"exact_snippets": "Tumor abutment or encasement (>180 degrees) of a short segment of the hepatic artery",
"criterion": "tumor abutment or encasement",
"requirements": [
{
"requirement_type": "location",
"expected_value": "hepatic artery"
},
{
"requirement_type": "degree",
"expected_value": {
"operator": ">",
"value": 180,
"unit": "degrees"
}
}
]
}
]
},
{
"line": "* Tumor induced narrowing of superior mesenteric vein, portal vein or superior mesenteric-portal vein of >50% of the diameter of the vessel.",
"criterions": [
{
"exact_snippets": "Tumor induced narrowing of superior mesenteric vein ... >50% of the diameter of the vessel.",
"criterion": "superior mesenteric vein narrowing",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "% of the diameter of the vessel"
}
}
]
},
{
"exact_snippets": "Tumor induced narrowing of ... portal vein ... >50% of the diameter of the vessel.",
"criterion": "portal vein narrowing",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "% of the diameter of the vessel"
}
}
]
},
{
"exact_snippets": "Tumor induced narrowing of ... superior mesenteric-portal vein ... >50% of the diameter of the vessel.",
"criterion": "superior mesenteric-portal vein narrowing",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "% of the diameter of the vessel"
}
}
]
}
]
},
{
"line": "* Short segment occlusion of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence with a suitable portal vein above and superior mesenteric vein below, for reconstruction",
"criterions": [
{
"exact_snippets": "Short segment occlusion of the superior mesenteric vein",
"criterion": "superior mesenteric vein occlusion",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "short segment"
}
]
},
{
"exact_snippets": "Short segment occlusion of the ... portal vein",
"criterion": "portal vein occlusion",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "short segment"
}
]
},
{
"exact_snippets": "Short segment occlusion of the ... superior mesenteric-portal vein confluence",
"criterion": "superior mesenteric-portal vein confluence occlusion",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "short segment"
}
]
},
{
"exact_snippets": "suitable portal vein above",
"criterion": "suitable portal vein",
"requirements": [
{
"requirement_type": "location",
"expected_value": "above"
}
]
},
{
"exact_snippets": "suitable ... superior mesenteric vein below",
"criterion": "suitable superior mesenteric vein",
"requirements": [
{
"requirement_type": "location",
"expected_value": "below"
}
]
}
]
},
{
"line": "* CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on multidisciplinary assessment at the Medical College of Wisconsin weekly pancreatic cancer conference)",
"criterions": [
{
"exact_snippets": "CT or MRI findings suspicious for, but not diagnostic of, metastatic disease",
"criterion": "metastatic disease",
"requirements": [
{
"requirement_type": "diagnostic status",
"expected_value": "suspicious but not diagnostic"
}
]
}
]
},
{
"line": "* Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound-guided fine needle aspirate",
"criterions": [
{
"exact_snippets": "Biopsy proven N1 disease (regional lymph nodes involved)",
"criterion": "N1 disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "pre-referral biopsy",
"criterion": "pre-referral biopsy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "endoscopic ultrasound-guided fine needle aspirate",
"criterion": "endoscopic ultrasound-guided fine needle aspirate",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Resectable tumor and cancer antigen 19-9 (CA19-9) >5000",
"criterions": [
{
"exact_snippets": "Resectable tumor",
"criterion": "tumor",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": true
}
]
},
{
"exact_snippets": "cancer antigen 19-9 (CA19-9) >5000",
"criterion": "cancer antigen 19-9 (CA19-9)",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 5000,
"unit": "N/A"
}
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "Inclusion criteria:",
"criterions": []
},
{
"line": "Treatment Eligibility Criteria:",
"criterions": []
}
]
}