Informações:
Falhas:
ID
38129
Descrição
Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification; ODM derived from: https://clinicaltrials.gov/show/NCT01839045
Link
https://clinicaltrials.gov/show/NCT01839045
Palavras-chave
Versões (1)
- 20/09/2019 20/09/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
20 de setembro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01839045
Eligibility Breast Cancer NCT01839045
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT01839045
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Adult | Gender | Age
Item
adult women from 25 years of age to below 50 years of age
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Breast Evaluation Result BI-RADS
Item
breast evaluation results of acr bi-rads® category 3 or 4 by imaging and physicians clinical and radiological evaluation
boolean
C0006141 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1511314 (UMLS CUI [1,4])
C1261322 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1511314 (UMLS CUI [1,4])
Clinical Trial Visit | Collection of blood specimen
Item
study visit and blood collection within 3 weeks (21 days) of acr bi-rads assessment
boolean
C0008976 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2])
C0545082 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2])
Agreement Follow-up | Agreement Collection of blood specimen | LCIS | DCIS
Item
patient agrees to return for diagnostic follow-up and blood collection at 6 months unless a positive cancer diagnosis is made between study visits 1 and 2. individuals diagnosed with lcis and dcis will agree to return for visit 2
boolean
C0680240 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0680240 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
C0279563 (UMLS CUI [3])
C0007124 (UMLS CUI [4])
C3274571 (UMLS CUI [1,2])
C0680240 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
C0279563 (UMLS CUI [3])
C0007124 (UMLS CUI [4])
Specimen Collection | Informed Consent
Item
samples collected under irb approval and informed consent
boolean
C0200345 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [2])
Testing
Item
testing performed under irb approval or waiver (as applicable)
boolean
C0039593 (UMLS CUI [1])
Adult | Age
Item
adults from 50 years of age or older and below 25 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Breast Evaluation Result BI-RADS
Item
final breast evaluation results other than a acr bi-rads category 3 or 4
boolean
C0006141 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1511314 (UMLS CUI [1,4])
C1261322 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1511314 (UMLS CUI [1,4])
Biopsy of breast
Item
subjects that have had a breast biopsy performed at any time prior to the study visit
boolean
C0405352 (UMLS CUI [1])
Specimen Collection Lacking | Informed Consent Lacking
Item
samples not collected under irb approval and informed consent
boolean
C0200345 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0332268 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Testing Absent
Item
testing not performed under irb approval or waiver (as applicable)
boolean
C0039593 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Breast Carcinoma Previous
Item
prior breast cancer diagnosis.
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])