ID

44768

Description

A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00989638

Link

https://clinicaltrials.gov/show/NCT00989638

Keywords

Versions (3)
  1. 7/16/16 7/16/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 11/17/21 11/17/21 -
Copyright Holder

University of Chicago

Uploaded on

November 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00989638

English

Eligibility Breast Cancer NCT00989638

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
known brca1 or brca2 carrier (regardless of age)
Description

brca1 or brca2 carrier

Data type

boolean

Alias
UMLS CUI [1]
C3899965
UMLS CUI [2]
C3899964
any mutation carrier in hereditary breast cancer susceptibility genes that is known to increase the risk for breast cancer (regardless of age). some examples of these would include tp53, pten, brca1 and brca2, chek2, atm, and cdh1.
Description

mutation carrier in hereditary breast cancer susceptibility genes

Data type

boolean

Alias
UMLS CUI [1,1]
C2985478
UMLS CUI [1,2]
C0346153
for women who chose not to have genetic testing or test negative, probability of being a brca1 or brca2 carrier of 20% or greater based on brcapro analysis or ≥ 25% risk of being a mutation carrier by couch model in addition to a lifetime breast cancer risk >=20% by gail, care, or claus model
Description

Risk of BRCA Mutation and breast cancer risk

Data type

boolean

Alias
UMLS CUI [1,1]
C1879774
UMLS CUI [1,2]
C1512362
UMLS CUI [2]
C1707405
UMLS CUI [3]
C1511297
personal history of breast cancer before age 35 years
Description

personal history of breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0262926
any woman of african ancestry whose 1st degree relative (mother or sister) or 2nd degree relative (aunt, grandmother) if paternal lineage suspected diagnosed with breast cancer under age 40, regardless of risk calculation
Description

Family history of breast cancer in African ancestry group

Data type

boolean

Alias
UMLS CUI [1]
C1257891
UMLS CUI [2]
C0559119
have a personal history of ductal carcinoma in situ (dcis) diagnosed at or before age 35 and a first degree relative who had been diagnosed with breast cancer before age 50 or has a first degree relative diagnosed with ovarian cancer at any age
Description

ductal carcinoma in situ (dis), family history of breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C0559119
any female cancer survivor who received chest irradiation before age 30 for any disease including hodgkin's, a sarcoma, neuroblastoma, or other medical condition.
Description

chest irradiation

Data type

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2]
C0019829
UMLS CUI [3]
C0027819
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women will be excluded if they meet one of the following:
Description

Exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
active cancer at the time of enrollment. a prior history of breast cancer is permitted if the subject has completed chemotherapy and is considered disease-free at the time of enrollment.
Description

active cancer or disease free breast cancer in history

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0242793
UMLS CUI [2,2]
C0006142
current pregnancy
Description

current pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0549206
presence of a pacemaker or any other metallic foreign objects in their body that interferes with an mri
Description

pacemaker or metallic foreign object

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C1720389
breast surgery within two weeks of study entry
Description

breast surgery

Data type

boolean

Alias
UMLS CUI [1]
C3714726
previous bilateral mastectomy (prophylactic or therapeutic)
Description

bilateral mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C0191877
history of kidney disease or abnormal kidney tests
Description

kidney disease or abnormal kidney tests

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0745526
women who test negative in a family with identifiable brca mutations are ineligible regardless of risk calculation
Description

BRCA Test negative

Data type

boolean

Alias
UMLS CUI [1]
C1445907
UMLS CUI [2]
C1445910
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Similar models

Eligibility Breast Cancer NCT00989638

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
brca1 or brca2 carrier
Item
known brca1 or brca2 carrier (regardless of age)
boolean
C3899965 (UMLS CUI [1])
C3899964 (UMLS CUI [2])
mutation carrier in hereditary breast cancer susceptibility genes
Item
any mutation carrier in hereditary breast cancer susceptibility genes that is known to increase the risk for breast cancer (regardless of age). some examples of these would include tp53, pten, brca1 and brca2, chek2, atm, and cdh1.
boolean
C2985478 (UMLS CUI [1,1])
C0346153 (UMLS CUI [1,2])
Risk of BRCA Mutation and breast cancer risk
Item
for women who chose not to have genetic testing or test negative, probability of being a brca1 or brca2 carrier of 20% or greater based on brcapro analysis or ≥ 25% risk of being a mutation carrier by couch model in addition to a lifetime breast cancer risk >=20% by gail, care, or claus model
boolean
C1879774 (UMLS CUI [1,1])
C1512362 (UMLS CUI [1,2])
C1707405 (UMLS CUI [2])
C1511297 (UMLS CUI [3])
personal history of breast cancer
Item
personal history of breast cancer before age 35 years
boolean
C0006142 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Family history of breast cancer in African ancestry group
Item
any woman of african ancestry whose 1st degree relative (mother or sister) or 2nd degree relative (aunt, grandmother) if paternal lineage suspected diagnosed with breast cancer under age 40, regardless of risk calculation
boolean
C1257891 (UMLS CUI [1])
C0559119 (UMLS CUI [2])
ductal carcinoma in situ (dis), family history of breast cancer
Item
have a personal history of ductal carcinoma in situ (dcis) diagnosed at or before age 35 and a first degree relative who had been diagnosed with breast cancer before age 50 or has a first degree relative diagnosed with ovarian cancer at any age
boolean
C0007124 (UMLS CUI [1])
C0559119 (UMLS CUI [2])
chest irradiation
Item
any female cancer survivor who received chest irradiation before age 30 for any disease including hodgkin's, a sarcoma, neuroblastoma, or other medical condition.
boolean
C4038705 (UMLS CUI [1])
C0019829 (UMLS CUI [2])
C0027819 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Exclusion criteria
Item
women will be excluded if they meet one of the following:
boolean
C0680251 (UMLS CUI [1])
active cancer or disease free breast cancer in history
Item
active cancer at the time of enrollment. a prior history of breast cancer is permitted if the subject has completed chemotherapy and is considered disease-free at the time of enrollment.
boolean
C0006826 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0242793 (UMLS CUI [2,1])
C0006142 (UMLS CUI [2,2])
current pregnancy
Item
current pregnancy
boolean
C0549206 (UMLS CUI [1])
pacemaker or metallic foreign object
Item
presence of a pacemaker or any other metallic foreign objects in their body that interferes with an mri
boolean
C0030163 (UMLS CUI [1])
C1720389 (UMLS CUI [2])
breast surgery
Item
breast surgery within two weeks of study entry
boolean
C3714726 (UMLS CUI [1])
bilateral mastectomy
Item
previous bilateral mastectomy (prophylactic or therapeutic)
boolean
C0191877 (UMLS CUI [1])
kidney disease or abnormal kidney tests
Item
history of kidney disease or abnormal kidney tests
boolean
C0022658 (UMLS CUI [1])
C0745526 (UMLS CUI [2])
BRCA Test negative
Item
women who test negative in a family with identifiable brca mutations are ineligible regardless of risk calculation
boolean
C1445907 (UMLS CUI [1])
C1445910 (UMLS CUI [2])
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