Information:
Fel:
ID
22532
Beskrivning
Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00603408
Länk
https://clinicaltrials.gov/show/NCT00603408
Nyckelord
Versioner (1)
- 07/06/17 07/06/17 -
Uppladdad den
7 giugno 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00603408
Eligibility Breast Cancer NCT00603408
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00603408
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
ID.1
Item
patients must be >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
boolean
C0011900 (UMLS CUI [1,1])
C1134719 (UMLS CUI [1,2])
C1134719 (UMLS CUI [1,2])
ID.3
Item
tumor classified as clinically stage t2, t3 or t4 with any n (nx, n1, n2, or n3).
boolean
C0178759 (UMLS CUI [1])
ID.4
Item
tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, her2/neu
boolean
C0041366 (UMLS CUI [1])
ID.5
Item
adequate organ function defined as:
boolean
C0678852 (UMLS CUI [1])
ID.6
Item
serum creatinine <= 1.5 x upper limit of institutional normal.
boolean
C0600061 (UMLS CUI [1])
ID.7
Item
alt, ast, alk phos <= 1.5 x upper limit of institutional normal.
boolean
C0001899 (UMLS CUI [1,1])
C0004002 (UMLS CUI [1,2])
C0002059 (UMLS CUI [1,3])
C0004002 (UMLS CUI [1,2])
C0002059 (UMLS CUI [1,3])
ID.8
Item
bilirubin <= 1.5 x upper limit of institutional normal.
boolean
C0005437 (UMLS CUI [1])
ID.9
Item
normal left ventricular function (lvef > 50%) by muga or echo.
boolean
C0080310 (UMLS CUI [1])
ID.10
Item
no evidence of distant metastasis present by ct, bone scan, or physical exam. if the bone scan or ct scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as pet or mri.
boolean
C0027627 (UMLS CUI [1])
ID.11
Item
no prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
boolean
C0455471 (UMLS CUI [1])
ID.12
Item
women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
boolean
C0232973 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,2])
ID.13
Item
karnofsky performance status of <= 70.
boolean
C0206065 (UMLS CUI [1])
ID.14
Item
patients with known history neural deficiencies (e.g. peripheral neuropathy).
boolean
C0027765 (UMLS CUI [1])
ID.15
Item
patients with a known hearing impairment (hearing loss or severe tinnitus).
boolean
C1384666 (UMLS CUI [1])
ID.16
Item
male patients
boolean
C0086582 (UMLS CUI [1])