Non-Small Cell Lung Carcinoma Advanced Local Unresectable TNM clinical staging | Pleural effusion | Non-small cell lung cancer metastatic TNM clinical staging
Item
histologically or cytologically confirmed, unresectable locally advanced (stage iiib with pleural effusion) and/or metastatic (stage iv) nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C3258246 (UMLS CUI [1,5])
C0032227 (UMLS CUI [2])
C0278987 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
Non-Small Cell Lung Carcinoma Advanced Therapeutic procedure Absent | Non-small cell lung cancer metastatic Therapeutic procedure Absent
Item
no previous therapy for advanced/metastatic nsclc is allowed
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease 2-Dimensional
Item
bidimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
Non-smoker | Former smoker Smoking cigarettes: ____ pack-years history
Item
non-smokers (or ex-smokers with less than 5 pack-years smoking history)
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C2230126 (UMLS CUI [2,2])
Adenocarcinoma
Item
adenocarcinoma histology
boolean
C0001418 (UMLS CUI [1])
WHO performance status scale
Item
performance status (who) 0-3
boolean
C1298650 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Renal function | Creatinine measurement, serum | Bone Marrow function | Neutrophil count | Platelet Count measurement
Item
adequate liver (serum bilirubin <1.5 times the upper normal limit (unl); ast and alt <2.5 times the unl in the absence of demonstrable liver metastases, or <5 times the unl in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the unl); and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0494165 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0494165 (UMLS CUI [6,1])
C0150312 (UMLS CUI [6,2])
C0232804 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C0031843 (UMLS CUI [9,2])
C0200633 (UMLS CUI [10])
C0032181 (UMLS CUI [11])
Radiotherapy, Adjuvant | Therapeutic radiology procedure Neoplasm Metastasis | Measurable lesion outside Radiation Field
Item
previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
boolean
C0242939 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0205101 (UMLS CUI [3,2])
C1882536 (UMLS CUI [3,3])
Able to swallow oral medication
Item
patient able to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Tissue sample available | Neoplasm mutation analysis
Item
tissue sample for tumour mutational analysis is required
boolean
C1292533 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0796357 (UMLS CUI [2,2])
Chronic disease of skin Serious Study Subject Participation Status Excluded | Psoriasis | Eczema
Item
serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
boolean
C1290009 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
C0033860 (UMLS CUI [2])
C0013595 (UMLS CUI [3])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia
Item
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
Malnutrition | Weight decreased Percentage | Body Weight
Item
malnutrition (loss of ≥ 20% of the original body weight)
boolean
C0162429 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0005910 (UMLS CUI [3])
performance status
Item
performance status: 4
boolean
C1518965 (UMLS CUI [1])
Mental disorder Protocol Compliance Excluded | Social situation Protocol Compliance Excluded
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])