ID

16308

Description

An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall; ODM derived from: https://clinicaltrials.gov/show/NCT00208871

Link

https://clinicaltrials.gov/show/NCT00208871

Keywords

Versions (1)
  1. 7/11/16 7/11/16 -
Uploaded on

July 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00208871

English

Eligibility Breast Cancer NCT00208871

1 forms  
Criteria
Description

Criteria

personal history of breast and/or ovarian cancer, regardless of age.
Description

Breast Carcinoma | Ovarian Carcinoma | Age Regardless

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0029925
UMLS CUI [3,1]
C0001779
UMLS CUI [3,2]
C3641650
prior breast biopsy that included any of the following high risk, benign lesion: lobular carcinoma in-situ, atypical ductal hyperplasia, atypical lobular hyperplasia, atypical columnar hyperplasia.
Description

Biopsy of breast | Lesion Benign High risk | lobular; carcinoma in situ, unspecified site | Atypical Ductal Breast Hyperplasia | Atypical lobular hyperplasia | Columnar Cell Hyperplasia of the Breast with Atypia

Data type

boolean

Alias
UMLS CUI [1]
C0405352
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205183
UMLS CUI [2,3]
C0332167
UMLS CUI [3]
C1391894
UMLS CUI [4]
C1332347
UMLS CUI [5]
C0442835
UMLS CUI [6]
C1707447
positive test for known mutations of brca 1 or 2 genes, regardless of age.
Description

BRCA1 gene mutation positive | BRCA2 gene mutation positive | Age Regardless

Data type

boolean

Alias
UMLS CUI [1]
C1445905
UMLS CUI [2]
C1445909
UMLS CUI [3,1]
C0001779
UMLS CUI [3,2]
C3641650
history of chest irradiation for treatment of non-breast disease (ex:lymphoma, lung cancer) at least 15 years prior to enrollment.
Description

irradiation of chest wall Breast Diseases | Lymphoma | Malignant neoplasm of lung

Data type

boolean

Alias
UMLS CUI [1,1]
C2064934
UMLS CUI [1,2]
C0006145
UMLS CUI [2]
C0024299
UMLS CUI [3]
C0242379
family history (over 30 years of age with any of the following, some exceptions may appy)
Description

Family history | Age

Data type

boolean

Alias
UMLS CUI [1]
C0241889
UMLS CUI [2]
C0001779
ashkenazi jewish ancestry, regardless of age.
Description

Ashkenazi Jewish ancestry | Age Regardless

Data type

boolean

Alias
UMLS CUI [1]
C2135555
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C3641650
any history of male breast cancer on the maternal or paternal side.
Description

Carcinoma of Male Breast Maternal Relative | Carcinoma of Male Breast Paternal Relative

Data type

boolean

Alias
UMLS CUI [1,1]
C0238033
UMLS CUI [1,2]
C2347083
UMLS CUI [2,1]
C0238033
UMLS CUI [2,2]
C2347452
breast and ovarian cancer in a close relative (mother, sister, daughter)
Description

Breast Carcinoma Biological Relative | Ovarian Carcinoma Biological Relative

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1266852
UMLS CUI [2,1]
C0029925
UMLS CUI [2,2]
C1266852
breast or ovarian cancer in more than one close relative (mother,sister daughter)
Description

Breast Carcinoma Biological Relative Quantity | Ovarian Carcinoma Biological Relative Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1266852
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0029925
UMLS CUI [2,2]
C1266852
UMLS CUI [2,3]
C1265611
breast cancer in a close relative (mother, sister, daughter) with early onset(<50 years of age)
Description

Breast Carcinoma Early-onset Biological Relative | Ovarian Carcinoma Early-onset Biological Relative | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1833334
UMLS CUI [1,3]
C1266852
UMLS CUI [2,1]
C0029925
UMLS CUI [2,2]
C1833334
UMLS CUI [2,3]
C1266852
UMLS CUI [3]
C0001779
breast and ovarian cancer in a 2nd. degree relative (grandmother, aunt, niece) with early onset of breast cancer. (<50 years of age)
Description

Breast Carcinoma Early-onset Second Degree Relative | Ovarian Carcinoma Second Degree Relative | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1833334
UMLS CUI [1,3]
C1519210
UMLS CUI [2,1]
C0029925
UMLS CUI [2,2]
C1519210
UMLS CUI [3]
C0001779
multiple history of breast cancer in 1st. and 2nd. degree relatives.
Description

Breast Carcinoma First Degree Relative | Breast Carcinoma Second Degree Relative

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1517194
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1519210
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient does not meet any of the inclusion criteria,
Description

Inclusion criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy,
Description

Augmentation mammoplasty | Augmentation mammoplasty Unilateral Due to Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C0191925
UMLS CUI [2,1]
C0191925
UMLS CUI [2,2]
C0205092
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0024881
patient has suspected or confirmed pregnancy,
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the ge senographe 2000d digital mammography unit.
Description

both breasts large Inappropriate Mammography

Data type

boolean

Alias
UMLS CUI [1,1]
C2111579
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0848600
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Similar models

Eligibility Breast Cancer NCT00208871

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma | Ovarian Carcinoma | Age Regardless
Item
personal history of breast and/or ovarian cancer, regardless of age.
boolean
C0678222 (UMLS CUI [1])
C0029925 (UMLS CUI [2])
C0001779 (UMLS CUI [3,1])
C3641650 (UMLS CUI [3,2])
Biopsy of breast | Lesion Benign High risk | lobular; carcinoma in situ, unspecified site | Atypical Ductal Breast Hyperplasia | Atypical lobular hyperplasia | Columnar Cell Hyperplasia of the Breast with Atypia
Item
prior breast biopsy that included any of the following high risk, benign lesion: lobular carcinoma in-situ, atypical ductal hyperplasia, atypical lobular hyperplasia, atypical columnar hyperplasia.
boolean
C0405352 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0205183 (UMLS CUI [2,2])
C0332167 (UMLS CUI [2,3])
C1391894 (UMLS CUI [3])
C1332347 (UMLS CUI [4])
C0442835 (UMLS CUI [5])
C1707447 (UMLS CUI [6])
BRCA1 gene mutation positive | BRCA2 gene mutation positive | Age Regardless
Item
positive test for known mutations of brca 1 or 2 genes, regardless of age.
boolean
C1445905 (UMLS CUI [1])
C1445909 (UMLS CUI [2])
C0001779 (UMLS CUI [3,1])
C3641650 (UMLS CUI [3,2])
irradiation of chest wall Breast Diseases | Lymphoma | Malignant neoplasm of lung
Item
history of chest irradiation for treatment of non-breast disease (ex:lymphoma, lung cancer) at least 15 years prior to enrollment.
boolean
C2064934 (UMLS CUI [1,1])
C0006145 (UMLS CUI [1,2])
C0024299 (UMLS CUI [2])
C0242379 (UMLS CUI [3])
Family history | Age
Item
family history (over 30 years of age with any of the following, some exceptions may appy)
boolean
C0241889 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Ashkenazi Jewish ancestry | Age Regardless
Item
ashkenazi jewish ancestry, regardless of age.
boolean
C2135555 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C3641650 (UMLS CUI [2,2])
Carcinoma of Male Breast Maternal Relative | Carcinoma of Male Breast Paternal Relative
Item
any history of male breast cancer on the maternal or paternal side.
boolean
C0238033 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0238033 (UMLS CUI [2,1])
C2347452 (UMLS CUI [2,2])
Breast Carcinoma Biological Relative | Ovarian Carcinoma Biological Relative
Item
breast and ovarian cancer in a close relative (mother, sister, daughter)
boolean
C0678222 (UMLS CUI [1,1])
C1266852 (UMLS CUI [1,2])
C0029925 (UMLS CUI [2,1])
C1266852 (UMLS CUI [2,2])
Breast Carcinoma Biological Relative Quantity | Ovarian Carcinoma Biological Relative Quantity
Item
breast or ovarian cancer in more than one close relative (mother,sister daughter)
boolean
C0678222 (UMLS CUI [1,1])
C1266852 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0029925 (UMLS CUI [2,1])
C1266852 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Breast Carcinoma Early-onset Biological Relative | Ovarian Carcinoma Early-onset Biological Relative | Age
Item
breast cancer in a close relative (mother, sister, daughter) with early onset(<50 years of age)
boolean
C0678222 (UMLS CUI [1,1])
C1833334 (UMLS CUI [1,2])
C1266852 (UMLS CUI [1,3])
C0029925 (UMLS CUI [2,1])
C1833334 (UMLS CUI [2,2])
C1266852 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Breast Carcinoma Early-onset Second Degree Relative | Ovarian Carcinoma Second Degree Relative | Age
Item
breast and ovarian cancer in a 2nd. degree relative (grandmother, aunt, niece) with early onset of breast cancer. (<50 years of age)
boolean
C0678222 (UMLS CUI [1,1])
C1833334 (UMLS CUI [1,2])
C1519210 (UMLS CUI [1,3])
C0029925 (UMLS CUI [2,1])
C1519210 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Breast Carcinoma First Degree Relative | Breast Carcinoma Second Degree Relative
Item
multiple history of breast cancer in 1st. and 2nd. degree relatives.
boolean
C0678222 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C1519210 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Fulfill
Item
patient does not meet any of the inclusion criteria,
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Augmentation mammoplasty | Augmentation mammoplasty Unilateral Due to Mastectomy
Item
patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy,
boolean
C0191925 (UMLS CUI [1])
C0191925 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0024881 (UMLS CUI [2,4])
Pregnancy
Item
patient has suspected or confirmed pregnancy,
boolean
C0032961 (UMLS CUI [1])
both breasts large Inappropriate Mammography
Item
patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the ge senographe 2000d digital mammography unit.
boolean
C2111579 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0848600 (UMLS CUI [1,3])
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