ID

38129

Descripción

Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification; ODM derived from: https://clinicaltrials.gov/show/NCT01839045

Link

https://clinicaltrials.gov/show/NCT01839045

Palabras clave

Versiones (1)
  1. 20/9/19 20/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01839045

Inglés

Eligibility Breast Cancer NCT01839045

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult women from 25 years of age to below 50 years of age
Descripción

Adult | Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
breast evaluation results of acr bi-rads® category 3 or 4 by imaging and physicians clinical and radiological evaluation
Descripción

Breast Evaluation Result BI-RADS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1511314
study visit and blood collection within 3 weeks (21 days) of acr bi-rads assessment
Descripción

Clinical Trial Visit | Collection of blood specimen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0545082
UMLS CUI [2]
C0005834
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
Descripción

Agreement Follow-up | Agreement Collection of blood specimen | LCIS | DCIS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C3274571
UMLS CUI [2,1]
C0680240
UMLS CUI [2,2]
C0005834
UMLS CUI [3]
C0279563
UMLS CUI [4]
C0007124
samples collected under irb approval and informed consent
Descripción

Specimen Collection | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200345
UMLS CUI [2]
C0021430
testing performed under irb approval or waiver (as applicable)
Descripción

Testing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0039593
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
adults from 50 years of age or older and below 25 years of age
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
final breast evaluation results other than a acr bi-rads category 3 or 4
Descripción

Breast Evaluation Result BI-RADS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1511314
subjects that have had a breast biopsy performed at any time prior to the study visit
Descripción

Biopsy of breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0405352
samples not collected under irb approval and informed consent
Descripción

Specimen Collection Lacking | Informed Consent Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0332268
testing not performed under irb approval or waiver (as applicable)
Descripción

Testing Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C0332197
prior breast cancer diagnosis.
Descripción

Breast Carcinoma Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
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Similar models

Eligibility Breast Cancer NCT01839045

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Specimen Collection | Informed Consent
Item
samples collected under irb approval and informed consent
boolean
C0200345 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Testing
Item
testing performed under irb approval or waiver (as applicable)
boolean
C0039593 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
Testing Absent
Item
testing not performed under irb approval or waiver (as applicable)
boolean
C0039593 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Breast Carcinoma Previous
Item
prior breast cancer diagnosis.
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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