ID

27192

Description

X-Ray Mammography Standard of Care Protocol; ODM derived from: https://clinicaltrials.gov/show/NCT01052740

Link

https://clinicaltrials.gov/show/NCT01052740

Keywords

Versions (1)
  1. 11/3/17 11/3/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01052740

English

Eligibility Breast Cancer NCT01052740

1 forms  
Criteria
Description

Criteria

women who are clinically indicated for screening mammography according to the national comprehensive cancer network (nccn) guidelines (3) and the american cancer society guidelines:
Description

Gender | Indication Screening mammography

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0203028
1. all women who fall under the acs mammography guidelines
Description

Gender | American Cancer Society Guidelines

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0002455
UMLS CUI [2,2]
C0162791
2. women younger than 40 years but with more than 20% lifetime risk for developing breast cancer:
Description

Gender | Lifetime Risk Percentage Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1517878
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0678222
1. prior personal history of prior thoracic radiation therapy between the age of 10 and 30, such as for hodgkin's disease. in this case, women are eligible beginning 8-10 years after radiotherapy or at age 40, whichever comes first.
Description

Radiotherapy to thorax | Age | Hodgkin Disease

Data type

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0019829
2. 5-year risk of invasive breast cancer (greater than or equal to 1.7% of women greater than or equal to 35 years or women who have a life time risk greater than 20% as defined by models that are largely dependent on family history.
Description

Risk Year Quantity Invasive carcinoma of breast | Gender | Age | Lifetime Risk Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0853879
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C1517878
UMLS CUI [4,2]
C0439165
3. strong family history;
Description

Family history Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0442821
i. first degree relative diagnosed with breast, ovarian, fallopian tube, or primary peritoneal cancer.
Description

First Degree Relative Breast Carcinoma | First Degree Relative Ovarian Carcinoma | First Degree Relative Fallopian Tube Carcinoma | First Degree Relative Malignant tumor of peritoneum Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C0029925
UMLS CUI [3,1]
C1517194
UMLS CUI [3,2]
C0238122
UMLS CUI [4,1]
C1517194
UMLS CUI [4,2]
C0153467
UMLS CUI [4,3]
C0205225
ii. individual from families known to have brca 1 or 2 gene mutation.
Description

Family member BRCA1 gene mutation | Family member BRCA2 gene mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0086282
UMLS CUI [1,2]
C1511022
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C1511024
iii. close male blood relative with breast cancer.
Description

Gender Blood Relative Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1266852
UMLS CUI [1,3]
C0678222
d. genetic predisposition;
Description

Predisposition Genetic

Data type

boolean

Alias
UMLS CUI [1,1]
C0220898
UMLS CUI [1,2]
C0314603
i. carry or have first-degree relative who carries a genetic mutation in the brca 1 or 2 genes.
Description

BRCA1 Mutation Carrier | BRCA2 Mutation Carrier | First Degree Relative BRCA1 Mutation Carrier | First Degree Relative BRCA2 Mutation Carrier

Data type

boolean

Alias
UMLS CUI [1]
C3899965
UMLS CUI [2]
C3899964
UMLS CUI [3,1]
C1517194
UMLS CUI [3,2]
C3899965
UMLS CUI [4,1]
C1517194
UMLS CUI [4,2]
C3899964
ii. carry or have a first-degree relative who carries a genetic mutation in the tp53 or pten genes (li-fraumeni syndrome and cowden bannayan-riley-ruvalcaba syndromes).
Description

TP53 Gene Mutation | First Degree Relative TP53 Gene Mutation | PTEN gene mutation | First Degree Relative PTEN gene mutation | Li-Fraumeni Syndrome | Bannayan-Riley-Ruvalcaba Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C3897380
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C3897380
UMLS CUI [3]
C3267001
UMLS CUI [4,1]
C1517194
UMLS CUI [4,2]
C3267001
UMLS CUI [5]
C0085390
UMLS CUI [6]
C0265326
e. a personal history of lobular carcinoma in situ (lcis) and/or atypical ductal hyperplasia (adh)
Description

Lobular carcinoma in situ | Atypical Ductal Hyperplasia

Data type

boolean

Alias
UMLS CUI [1]
C0279563
UMLS CUI [2]
C1332347
f. prior personal history of breast cancer or ovarian cancer.
Description

Breast Carcinoma | Ovarian Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0029925
i. starting at the age of 25 year for hereditary breast and ovarian cancer patients.
Description

Age | Hereditary Breast Cancer | Ovarian Carcinoma Hereditary

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0346153
UMLS CUI [3,1]
C0029925
UMLS CUI [3,2]
C0439660
ii. 5-10 years prior to youngest breast cancer case for strong family history or other genetic predisposition.
Description

Year Quantity Before Breast Carcinoma | Family history Strong | Predisposition Genetic

Data type

boolean

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0678222
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C0220898
UMLS CUI [3,2]
C0314603
g. woman and minorities
Description

Gender | Minorities

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0026192
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating subjects.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT01052740

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Gender | Indication Screening mammography
Item
women who are clinically indicated for screening mammography according to the national comprehensive cancer network (nccn) guidelines (3) and the american cancer society guidelines:
boolean
C0079399 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0203028 (UMLS CUI [2,2])
Gender | American Cancer Society Guidelines
Item
1. all women who fall under the acs mammography guidelines
boolean
C0079399 (UMLS CUI [1])
C0002455 (UMLS CUI [2,1])
C0162791 (UMLS CUI [2,2])
Gender | Lifetime Risk Percentage Breast Carcinoma
Item
2. women younger than 40 years but with more than 20% lifetime risk for developing breast cancer:
boolean
C0079399 (UMLS CUI [1])
C1517878 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Radiotherapy to thorax | Age | Hodgkin Disease
Item
1. prior personal history of prior thoracic radiation therapy between the age of 10 and 30, such as for hodgkin's disease. in this case, women are eligible beginning 8-10 years after radiotherapy or at age 40, whichever comes first.
boolean
C4038705 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0019829 (UMLS CUI [3])
Risk Year Quantity Invasive carcinoma of breast | Gender | Age | Lifetime Risk Percentage
Item
2. 5-year risk of invasive breast cancer (greater than or equal to 1.7% of women greater than or equal to 35 years or women who have a life time risk greater than 20% as defined by models that are largely dependent on family history.
boolean
C0035647 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0853879 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1517878 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
Family history Strong
Item
3. strong family history;
boolean
C0241889 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
First Degree Relative Breast Carcinoma | First Degree Relative Ovarian Carcinoma | First Degree Relative Fallopian Tube Carcinoma | First Degree Relative Malignant tumor of peritoneum Primary
Item
i. first degree relative diagnosed with breast, ovarian, fallopian tube, or primary peritoneal cancer.
boolean
C1517194 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1517194 (UMLS CUI [2,1])
C0029925 (UMLS CUI [2,2])
C1517194 (UMLS CUI [3,1])
C0238122 (UMLS CUI [3,2])
C1517194 (UMLS CUI [4,1])
C0153467 (UMLS CUI [4,2])
C0205225 (UMLS CUI [4,3])
Family member BRCA1 gene mutation | Family member BRCA2 gene mutation
Item
ii. individual from families known to have brca 1 or 2 gene mutation.
boolean
C0086282 (UMLS CUI [1,1])
C1511022 (UMLS CUI [1,2])
C0086282 (UMLS CUI [2,1])
C1511024 (UMLS CUI [2,2])
Gender Blood Relative Breast Carcinoma
Item
iii. close male blood relative with breast cancer.
boolean
C0079399 (UMLS CUI [1,1])
C1266852 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Predisposition Genetic
Item
d. genetic predisposition;
boolean
C0220898 (UMLS CUI [1,1])
C0314603 (UMLS CUI [1,2])
BRCA1 Mutation Carrier | BRCA2 Mutation Carrier | First Degree Relative BRCA1 Mutation Carrier | First Degree Relative BRCA2 Mutation Carrier
Item
i. carry or have first-degree relative who carries a genetic mutation in the brca 1 or 2 genes.
boolean
C3899965 (UMLS CUI [1])
C3899964 (UMLS CUI [2])
C1517194 (UMLS CUI [3,1])
C3899965 (UMLS CUI [3,2])
C1517194 (UMLS CUI [4,1])
C3899964 (UMLS CUI [4,2])
TP53 Gene Mutation | First Degree Relative TP53 Gene Mutation | PTEN gene mutation | First Degree Relative PTEN gene mutation | Li-Fraumeni Syndrome | Bannayan-Riley-Ruvalcaba Syndrome
Item
ii. carry or have a first-degree relative who carries a genetic mutation in the tp53 or pten genes (li-fraumeni syndrome and cowden bannayan-riley-ruvalcaba syndromes).
boolean
C3897380 (UMLS CUI [1])
C1517194 (UMLS CUI [2,1])
C3897380 (UMLS CUI [2,2])
C3267001 (UMLS CUI [3])
C1517194 (UMLS CUI [4,1])
C3267001 (UMLS CUI [4,2])
C0085390 (UMLS CUI [5])
C0265326 (UMLS CUI [6])
Lobular carcinoma in situ | Atypical Ductal Hyperplasia
Item
e. a personal history of lobular carcinoma in situ (lcis) and/or atypical ductal hyperplasia (adh)
boolean
C0279563 (UMLS CUI [1])
C1332347 (UMLS CUI [2])
Breast Carcinoma | Ovarian Carcinoma
Item
f. prior personal history of breast cancer or ovarian cancer.
boolean
C0678222 (UMLS CUI [1])
C0029925 (UMLS CUI [2])
Age | Hereditary Breast Cancer | Ovarian Carcinoma Hereditary
Item
i. starting at the age of 25 year for hereditary breast and ovarian cancer patients.
boolean
C0001779 (UMLS CUI [1])
C0346153 (UMLS CUI [2])
C0029925 (UMLS CUI [3,1])
C0439660 (UMLS CUI [3,2])
Year Quantity Before Breast Carcinoma | Family history Strong | Predisposition Genetic
Item
ii. 5-10 years prior to youngest breast cancer case for strong family history or other genetic predisposition.
boolean
C0439234 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0678222 (UMLS CUI [1,4])
C0241889 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0220898 (UMLS CUI [3,1])
C0314603 (UMLS CUI [3,2])
Gender | Minorities
Item
g. woman and minorities
boolean
C0079399 (UMLS CUI [1])
C0026192 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating subjects.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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