ID

38101

Description

Studying Changes in Breast Density in Patients With Early-Stage Breast Cancer Treated With Metformin Hydrochloride or Placebo on CAN-NCIC-MA.32; ODM derived from: https://clinicaltrials.gov/show/NCT01666171

Link

https://clinicaltrials.gov/show/NCT01666171

Keywords

Versions (1)
  1. 9/17/19 9/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01666171

English

Eligibility Breast Cancer NCT01666171

1 forms  
Criteria
Description

Criteria

patients must either be concurrently enrolling or previously enrolled to canada (can) national cancer institute of canada (ncic) study ma.32 (can-ncic-ma.32) (ma.32); eligible patients may be either pre- or post-menopausal
Description

Enrollment Clinical Trial Specified | Premenopausal state | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2]
C0232969
UMLS CUI [3]
C0232970
patients must have hormone receptor-negative breast cancer
Description

Breast Carcinoma Hormone Receptor Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019929
UMLS CUI [1,3]
C1513916
patients must have breast density ≥ 25% (correlating with the breast imaging-reporting and data [birad]-2 category of "scattered fibroglandular densities" or greater)
Description

Breast Density Percentage BI-RADS

Data type

boolean

Alias
UMLS CUI [1,1]
C1659543
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1511314
baseline digital mammograms taken within 12 months prior to registration to ma.32, with at least a craniocaudal (cc) view used for enrollment to ma.32 must be available for submission; if the patient has previously enrolled to ma.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission
Description

Digital mammogram Cranio-caudal projection

Data type

boolean

Alias
UMLS CUI [1,1]
C3862913
UMLS CUI [1,2]
C0442215
contralateral unaffected breast in place (with no prior cancer or radiation, no implants, and no plan for breast surgery on contralateral breast over the course of the study); women with a prior biopsy on the unaffected breast are eligible
Description

Breast Contralateral Unaffected | Cancer Previous Absent | Prior radiation therapy Absent | Breast implants Absent | Breast surgery Plan Absent | Biopsy Previous allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0441988
UMLS CUI [1,3]
C2986417
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0179412
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C3714726
UMLS CUI [5,2]
C1301732
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0005558
UMLS CUI [6,2]
C0205156
UMLS CUI [6,3]
C0683607
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
see disease characteristics
Description

ID.9

Data type

boolean

women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible
Description

Gender | Hormone Therapy | Tamoxifen | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0593802
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Similar models

Eligibility Breast Cancer NCT01666171

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Enrollment Clinical Trial Specified | Premenopausal state | Postmenopausal state
Item
patients must either be concurrently enrolling or previously enrolled to canada (can) national cancer institute of canada (ncic) study ma.32 (can-ncic-ma.32) (ma.32); eligible patients may be either pre- or post-menopausal
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0232969 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Breast Carcinoma Hormone Receptor Negative
Item
patients must have hormone receptor-negative breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0019929 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Breast Density Percentage BI-RADS
Item
patients must have breast density ≥ 25% (correlating with the breast imaging-reporting and data [birad]-2 category of "scattered fibroglandular densities" or greater)
boolean
C1659543 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1511314 (UMLS CUI [1,3])
Digital mammogram Cranio-caudal projection
Item
baseline digital mammograms taken within 12 months prior to registration to ma.32, with at least a craniocaudal (cc) view used for enrollment to ma.32 must be available for submission; if the patient has previously enrolled to ma.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission
boolean
C3862913 (UMLS CUI [1,1])
C0442215 (UMLS CUI [1,2])
Breast Contralateral Unaffected | Cancer Previous Absent | Prior radiation therapy Absent | Breast implants Absent | Breast surgery Plan Absent | Biopsy Previous allowed
Item
contralateral unaffected breast in place (with no prior cancer or radiation, no implants, and no plan for breast surgery on contralateral breast over the course of the study); women with a prior biopsy on the unaffected breast are eligible
boolean
C0006141 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
C2986417 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0179412 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C3714726 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0005558 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
ID.9
Item
see disease characteristics
boolean
Gender | Hormone Therapy | Tamoxifen | Aromatase Inhibitors
Item
women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible
boolean
C0079399 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
C0593802 (UMLS CUI [4])
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