Eligibility Carcinoma, Renal Cell NCT01107509

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StudyEvent: Eligibility
1. Eligibility Carcinoma, Renal Cell NCT01107509

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age | Capability Informed Consent

Item

at least 18 years of age and capable of giving informed consent

boolean

C0001779 (UMLS CUI [1])
C2698977 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])

Renal Cell Carcinoma CT scan TNM clinical staging | Neoplasm Metastasis

Item

radiological evidence of rcc consisting of: ct scan with stage t2, t3, t3a, t3b, t4, or any stage t with n1/ 2 and/ or metastatic disease

boolean

C0007134 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2])

Nephrectomy | Kidney biopsy Willing

Item

having a nephrectomy and willing to have a kidney biopsy

boolean

C0027695 (UMLS CUI [1])
C0194073 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])

ECOG performance status

Item

ecog score 0 or 1

boolean

C1520224 (UMLS CUI [1])

Clear cell Histology

Item

clear cell histology

boolean

C0229473 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])

HIV negative | Hepatitis B test negative | Hepatitis C test negative

Item

negative for hiv, hepatitis b, and hepatitis c

boolean

C0481430 (UMLS CUI [1])
C1611173 (UMLS CUI [2])
C1619717 (UMLS CUI [3])

Childbearing Potential Pregnancy test negative

Item

negative pregnancy test for women of child-bearing potential

boolean

C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Disease TNM clinical staging | Neoplasm Metastasis Absent

Item

stage t1 disease without metastases

boolean

C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])

Laboratory test result abnormal

Item

abnormal laboratory values at screening within the following ranges:

boolean

C0438215 (UMLS CUI [1])

Absolute neutrophil count | Platelet Count measurement

Item

absolute neutrophil count ≤ 1.5 × 109/ l; platelet count ≤ 100 × 109/ l

boolean

C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])

Item

leukocyte count ≤ 3 × 109/ l; hemoglobin ≤ 80 g/ l; serum creatinine ≥ 2.0 × the upper normal limit (unl); total bilirubin ≤ 1.5 × unl; ast and alt ≤ 3.0 × unl

boolean

C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])

Fasting cholesterol level | Serum fasting triglyceride measurement

Item

fasting serum cholesterol ≤ 9.0 mmol/ l; fasting serum triglycerides ≥ 5.0 mmol/l

boolean

C1282513 (UMLS CUI [1])
C0582824 (UMLS CUI [2])

Illness Major Study Subject Participation Status At risk

Item

any major illness that, based on the investigator's judgment, will substantially increase the risk associated with a subject's participation in this study

boolean

C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])

Cancer Other

Item

other currently active malignancies

boolean

C1707251 (UMLS CUI [1])

Pharmaceutical Preparations Interfere with Metabolism Everolimus

Item

currently taking any medications known to interfere with the metabolism of everolimus

boolean

C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0025519 (UMLS CUI [1,3])
C0541315 (UMLS CUI [1,4])

Anticoagulation Therapy | Warfarin

Item

receiving anticoagulation with warfarin

boolean

C0003281 (UMLS CUI [1])
C0043031 (UMLS CUI [2])

Pulmonary Hypertension | Lung Disease, Interstitial

Item

a history of pulmonary hypertension or interstitial lung disease

boolean

C0020542 (UMLS CUI [1])
C0206062 (UMLS CUI [2])

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Eligibility Carcinoma, Renal Cell NCT01107509