Eligibility Cancer NCT01078649

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01078649
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Solid Neoplasm | Lymphoma
Item
histologically confirmed solid tumor or lymphoma;
boolean
C0280100 (UMLS CUI [1])
C0024299 (UMLS CUI [2])
Advanced disease Locally | Neoplasm Metastasis | Prolongation of Life Therapy Unavailable | Standard of Care Inappropriate
Item
locally advanced or metastatic disease for which no life prolonging therapy is available and no standard therapy is judged appropriate by the investigator;
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0023677 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0686905 (UMLS CUI [3,3])
C2936643 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group performance status ≤ 1;
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
adequate hematologic function as indicated by, anc ≥ 1,500/mm3, hgb >9.0 g/dl, platelet count ≥ 100,000/mm3
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Renal function | Liver function | Creatinine measurement, serum | Creatinine clearance measurement | Serum albumin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
adequate renal and liver function as indicated by serum creatinine ≤ 1.0 x uln or creatinine clearance of > 60 cc/min, serum albumin ≥ 3.0 gm/dl, total bilirubin < 1.0 x uln, ast and alt ≤ 2.5 x uln ; alkaline phosphatase ≤2.5 x uln
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
C0523465 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201850 (UMLS CUI [9])
Hepatitis B test negative | Hepatitis C test negative
Item
negative hepatitis b and hepatitis c testing;
boolean
C1611173 (UMLS CUI [1])
C1619717 (UMLS CUI [2])
QTc interval
Item
qtc interval ≤450ms.
boolean
C0489625 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Radiotherapy to thorax | Prior radiation therapy | Steroids To be stopped
Item
radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. patients who have received prior radiotherapy must have discontinued steroids for 14 days prior to study entry and be clinically stable;
boolean
C1522449 (UMLS CUI [1])
C4038705 (UMLS CUI [2])
C0279134 (UMLS CUI [3])
C0038317 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
Toxicity Due to Prior radiation therapy | Toxicity Due to Prior Chemotherapy | Recovery Lacking | Toxicity CTCAE Grades
Item
not recovered to ≤ grade 1 toxicity from prior radiotherapy or chemotherapy agents;
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514457 (UMLS CUI [2,3])
C2004454 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
Use aspirin | Requirement Use aspirin | Pharmaceutical Preparations Containing Aspirin | Aspirin U/day
Item
use or requirement for use of aspirin or aspirin containing products with >81 mg of aspirin per day;
boolean
C1388856 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C1388856 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0004057 (UMLS CUI [3,3])
C0004057 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
Gastrointestinal Hemorrhage
Item
history of gastrointestinal bleeding within 1 year;
boolean
C0017181 (UMLS CUI [1])
Diabetes Mellitus Requirement Oral medication | Diabetes Mellitus Requirement Insulin regime
Item
history of diabetes mellitus requiring treatment with oral agents or insulin;
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0557978 (UMLS CUI [2,3])
Rheumatoid Arthritis | Inflammatory Bowel Disease | Chronic infectious disease | Disease Associated with Chronic inflammation | Condition Associated with Chronic inflammation
Item
active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation;
boolean
C0003873 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0021376 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0021376 (UMLS CUI [5,3])
Wilson's disease | Wilson's disease Suspected | Condition Affecting Copper accumulation | Condition Affecting Copper Regulation
Item
known or suspected wilson's disease, or other conditions that affect copper accumulation or regulation;
boolean
C0019202 (UMLS CUI [1])
C0019202 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C4227688 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0009968 (UMLS CUI [4,3])
C1327622 (UMLS CUI [4,4])
Apoptosis Inhibitor
Item
prior treatment with iap inhibitors.
boolean
C1332320 (UMLS CUI [1])
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