ID

37717

Description

Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01219075

Link

https://clinicaltrials.gov/show/NCT01219075

Keywords

Versions (1)
  1. 8/19/19 8/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility BRCA1 Mutation Carrier NCT01219075

English

Eligibility BRCA1 Mutation Carrier NCT01219075

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women at high risk for breast cancer, defined as any of the following groups:
Description

Gender | High risk of Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0678222
five year gail risk > 1.7%
Description

Gail Risk Model Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1511297
UMLS CUI [1,2]
C0439165
known brca1/brca2 mutation carrier
Description

BRCA1 Mutation Carrier | BRCA2 Mutation Carrier

Data type

boolean

Alias
UMLS CUI [1]
C3899965
UMLS CUI [2]
C3899964
family history consistent with hereditary breast cancer
Description

Family history Consistent with Hereditary Breast Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0346153
prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (lcis)
Description

Atypical hyperplasia | Lobular carcinoma in situ of breast

Data type

boolean

Alias
UMLS CUI [1]
C0333977
UMLS CUI [2]
C0279563
history of invasive breast cancer or ductal carcinoma in situ (dcis) and have completed standard therapy including tamoxifen/aromatase inhibitor or will not be treated with tamoxifen/aromatase inhibitor
Description

Invasive carcinoma of breast | DCIS | Standard therapy Completed | Tamoxifen | Aromatase Inhibitors | Tamoxifen Absent | Aromatase Inhibitors Absent

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0007124
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0205197
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0593802
UMLS CUI [6,1]
C0039286
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0593802
UMLS CUI [7,2]
C0332197
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic breast cancer
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
undergoing treatment (chemotherapy, radiation, or serms)
Description

Therapeutic procedure | Chemotherapy | Therapeutic radiology procedure | SERMs

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0732611
pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
regular soy consumers (i.e., < once per week of soy food, soy supplements or other products)
Description

Soy Consumer Regular | Soy Food | Soy Supplements | Soy product

Data type

boolean

Alias
UMLS CUI [1,1]
C0037733
UMLS CUI [1,2]
C1707496
UMLS CUI [1,3]
C0205272
UMLS CUI [2]
C1258091
UMLS CUI [3,1]
C0037733
UMLS CUI [3,2]
C0242295
UMLS CUI [4]
C1532456
known food allergies such as to soy or nuts
Description

Food Allergy | Allergy to soy | Nut Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0016470
UMLS CUI [2]
C4075590
UMLS CUI [3]
C0577620
not willing to avoid soy foods/supplements during study period
Description

Avoidance Soy Foods Unwilling | Avoidance Soy Supplements Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C1258091
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0037733
UMLS CUI [2,3]
C0242295
UMLS CUI [2,4]
C0558080
current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
Description

Use of Exogenous hormones | Use of Oral Contraceptives | Use of Exogenous hormones Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0450231
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0009905
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0450231
UMLS CUI [3,3]
C1301732
cannot stop taking aspirin or nsaids within a week of breast biopsy
Description

Aspirin Discontinue Unable | NSAIDs Discontinue Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1299582
active participant in other ongoing trials
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility BRCA1 Mutation Carrier NCT01219075

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | High risk of Breast Carcinoma
Item
women at high risk for breast cancer, defined as any of the following groups:
boolean
C0079399 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Gail Risk Model Percentage
Item
five year gail risk > 1.7%
boolean
C1511297 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
BRCA1 Mutation Carrier | BRCA2 Mutation Carrier
Item
known brca1/brca2 mutation carrier
boolean
C3899965 (UMLS CUI [1])
C3899964 (UMLS CUI [2])
Family history Consistent with Hereditary Breast Cancer
Item
family history consistent with hereditary breast cancer
boolean
C0241889 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0346153 (UMLS CUI [1,3])
Atypical hyperplasia | Lobular carcinoma in situ of breast
Item
prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (lcis)
boolean
C0333977 (UMLS CUI [1])
C0279563 (UMLS CUI [2])
Invasive carcinoma of breast | DCIS | Standard therapy Completed | Tamoxifen | Aromatase Inhibitors | Tamoxifen Absent | Aromatase Inhibitors Absent
Item
history of invasive breast cancer or ductal carcinoma in situ (dcis) and have completed standard therapy including tamoxifen/aromatase inhibitor or will not be treated with tamoxifen/aromatase inhibitor
boolean
C0853879 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C2936643 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
C0039286 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0593802 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Therapeutic procedure | Chemotherapy | Therapeutic radiology procedure | SERMs
Item
undergoing treatment (chemotherapy, radiation, or serms)
boolean
C0087111 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0732611 (UMLS CUI [4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Soy Consumer Regular | Soy Food | Soy Supplements | Soy product
Item
regular soy consumers (i.e., < once per week of soy food, soy supplements or other products)
boolean
C0037733 (UMLS CUI [1,1])
C1707496 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C1258091 (UMLS CUI [2])
C0037733 (UMLS CUI [3,1])
C0242295 (UMLS CUI [3,2])
C1532456 (UMLS CUI [4])
Food Allergy | Allergy to soy | Nut Hypersensitivity
Item
known food allergies such as to soy or nuts
boolean
C0016470 (UMLS CUI [1])
C4075590 (UMLS CUI [2])
C0577620 (UMLS CUI [3])
Avoidance Soy Foods Unwilling | Avoidance Soy Supplements Unwilling
Item
not willing to avoid soy foods/supplements during study period
boolean
C0870186 (UMLS CUI [1,1])
C1258091 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0870186 (UMLS CUI [2,1])
C0037733 (UMLS CUI [2,2])
C0242295 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Use of Exogenous hormones | Use of Oral Contraceptives | Use of Exogenous hormones Planned
Item
current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
boolean
C1524063 (UMLS CUI [1,1])
C0450231 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0009905 (UMLS CUI [2,2])
C1524063 (UMLS CUI [3,1])
C0450231 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
Aspirin Discontinue Unable | NSAIDs Discontinue Unable
Item
cannot stop taking aspirin or nsaids within a week of breast biopsy
boolean
C0004057 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Study Subject Participation Status
Item
active participant in other ongoing trials
boolean
C2348568 (UMLS CUI [1])
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