ID

38035

Description

Epigenetic Testing for Breast Cancer Risk Stratification; ODM derived from: https://clinicaltrials.gov/show/NCT01501656

Link

https://clinicaltrials.gov/show/NCT01501656

Keywords

Versions (1)
  1. 9/10/19 9/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01501656

English

Eligibility Breast Cancer NCT01501656

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women between the ages of 30 and 79.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
untreated stage 1 - 3 invasive breast cancer or a woman never diagnosed with breast cancer.
Description

Invasive carcinoma of breast Untreated TNM Breast tumor staging | Gender Breast Carcinoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0332197
bi-rads 1, 2, or 3 breast imaging within 12 months for women >40 years of age recruited into the control group.
Description

BI-RADS Breast imaging study | Gender | Age | Control Group

Data type

boolean

Alias
UMLS CUI [1,1]
C1511314
UMLS CUI [1,2]
C1134632
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0009932
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
<30 or >80 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
unable to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
presence of an undefined palpable or mammographic breast lesion suspicious for malignancy (birads 4 or 5)
Description

Lesion of breast Palpable Suspicious for Malignancy | Lesion of breast Mammography Suspicious for Malignancy | Lesion of breast BI-RADS

Data type

boolean

Alias
UMLS CUI [1,1]
C0567489
UMLS CUI [1,2]
C0522499
UMLS CUI [1,3]
C4050405
UMLS CUI [2,1]
C0567489
UMLS CUI [2,2]
C0024671
UMLS CUI [2,3]
C4050405
UMLS CUI [3,1]
C0567489
UMLS CUI [3,2]
C1511314
breast implants
Description

Breast implants

Data type

boolean

Alias
UMLS CUI [1]
C0179412
bilateral prophylactic mastectomy
Description

Bilateral Prophylactic Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C1706504
any prior breasts irradiation
Description

Irradiation of breast Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2148528
UMLS CUI [1,2]
C0205156
any systemic chemotherapy in the past
Description

Systemic Chemotherapy In the past

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1444637
performance status that restricted normal activity for a significant portion of the day
Description

Performance status | Activity Normal Restricted

Data type

boolean

Alias
UMLS CUI [1]
C1518965
UMLS CUI [2,1]
C0441655
UMLS CUI [2,2]
C0205307
UMLS CUI [2,3]
C0443288
use of luteinizing-hormone-releasing-hormone (lhrh) analogs, prolactin inhibitors, antiandrogens, or systemic glucocorticoids within three months
Description

LH-RH Analogs | Prolactin inhibitors | Androgen Antagonists | Glucocorticoids, Systemic

Data type

boolean

Alias
UMLS CUI [1]
C1518041
UMLS CUI [2,1]
C0033371
UMLS CUI [2,2]
C0243077
UMLS CUI [3]
C0002842
UMLS CUI [4]
C3540777
ever use of tamoxifen, raloxifene, or other serms
Description

Tamoxifen | Raloxifene | Selective Estrogen Receptor Modulators

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0244404
UMLS CUI [3]
C0732611
ever use of aromatase inhibitors
Description

Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0593802
pregnancy or lactation within six months
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
bleeding diathesis of any kind
Description

Bleeding tendency Kind Any

Data type

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
1. inherited coagulation disorder
Description

Blood Coagulation Disorders, Inherited

Data type

boolean

Alias
UMLS CUI [1]
C0852077
2. current coumadin use
Description

COUMADIN USE

Data type

boolean

Alias
UMLS CUI [1]
C0239136
3. use of drugs that inhibit platelet aggregation within 10 days
Description

Pharmaceutical Preparations Preventing Platelet aggregation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0032176
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Similar models

Eligibility Breast Cancer NCT01501656

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women between the ages of 30 and 79.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast Untreated TNM Breast tumor staging | Gender Breast Carcinoma Absent
Item
untreated stage 1 - 3 invasive breast cancer or a woman never diagnosed with breast cancer.
boolean
C0853879 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
BI-RADS Breast imaging study | Gender | Age | Control Group
Item
bi-rads 1, 2, or 3 breast imaging within 12 months for women >40 years of age recruited into the control group.
boolean
C1511314 (UMLS CUI [1,1])
C1134632 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0009932 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Age
Item
<30 or >80 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable
Item
unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Lesion of breast Palpable Suspicious for Malignancy | Lesion of breast Mammography Suspicious for Malignancy | Lesion of breast BI-RADS
Item
presence of an undefined palpable or mammographic breast lesion suspicious for malignancy (birads 4 or 5)
boolean
C0567489 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C4050405 (UMLS CUI [1,3])
C0567489 (UMLS CUI [2,1])
C0024671 (UMLS CUI [2,2])
C4050405 (UMLS CUI [2,3])
C0567489 (UMLS CUI [3,1])
C1511314 (UMLS CUI [3,2])
Breast implants
Item
breast implants
boolean
C0179412 (UMLS CUI [1])
Bilateral Prophylactic Mastectomy
Item
bilateral prophylactic mastectomy
boolean
C1706504 (UMLS CUI [1])
Irradiation of breast Previous
Item
any prior breasts irradiation
boolean
C2148528 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Systemic Chemotherapy In the past
Item
any systemic chemotherapy in the past
boolean
C1883256 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Performance status | Activity Normal Restricted
Item
performance status that restricted normal activity for a significant portion of the day
boolean
C1518965 (UMLS CUI [1])
C0441655 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0443288 (UMLS CUI [2,3])
LH-RH Analogs | Prolactin inhibitors | Androgen Antagonists | Glucocorticoids, Systemic
Item
use of luteinizing-hormone-releasing-hormone (lhrh) analogs, prolactin inhibitors, antiandrogens, or systemic glucocorticoids within three months
boolean
C1518041 (UMLS CUI [1])
C0033371 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C0002842 (UMLS CUI [3])
C3540777 (UMLS CUI [4])
Tamoxifen | Raloxifene | Selective Estrogen Receptor Modulators
Item
ever use of tamoxifen, raloxifene, or other serms
boolean
C0039286 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
C0732611 (UMLS CUI [3])
Aromatase Inhibitors
Item
ever use of aromatase inhibitors
boolean
C0593802 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation within six months
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Bleeding tendency Kind Any
Item
bleeding diathesis of any kind
boolean
C1458140 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Blood Coagulation Disorders, Inherited
Item
1. inherited coagulation disorder
boolean
C0852077 (UMLS CUI [1])
COUMADIN USE
Item
2. current coumadin use
boolean
C0239136 (UMLS CUI [1])
Pharmaceutical Preparations Preventing Platelet aggregation
Item
3. use of drugs that inhibit platelet aggregation within 10 days
boolean
C0013227 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0032176 (UMLS CUI [1,3])
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