ID

16410

Beschrijving

Adherence to Intensive Surveillance for Hereditary Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00582803

Link

https://clinicaltrials.gov/show/NCT00582803

Trefwoorden

Versies (1)
  1. 15-07-16 15-07-16 -
Geüploaded op

15 juli 2016

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00582803

Engels

Eligibility Breast Cancer NCT00582803

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
age 25 years or greater
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
genetic predisposition as defined by one of the following:
Beschrijving

Genetic Predisposition

Datatype

boolean

Alias
UMLS CUI [1]
C0314657
known brca1 or brca2 mutation (deleterious or uncertain significance) or
Beschrijving

BRCA1 gene mutation Deleterious | BRCA2 gene mutation Deleterious | BRCA1 gene mutation Significance undetermined | BRCA2 gene mutation Significance undetermined

Datatype

boolean

Alias
UMLS CUI [1,1]
C1511022
UMLS CUI [1,2]
C2985436
UMLS CUI [2,1]
C1511024
UMLS CUI [2,2]
C2985436
UMLS CUI [3,1]
C1511022
UMLS CUI [3,2]
C1272585
UMLS CUI [4,1]
C1511024
UMLS CUI [4,2]
C1272585
untested first-degree relative of an individual with a known deleterious brca mutation or
Beschrijving

brca gene Deleterious Mutation | First Degree Relative Tested

Datatype

boolean

Alias
UMLS CUI [1,1]
C0596223
UMLS CUI [1,2]
C2985436
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C0392366
unaffected first-degree relative of an affected individual within a hereditary breast-ovarian kindred in which no testing has been performed or testing is negative, defined as: 3 or more women in 2 generations affected with breast or ovarian cancer. women with bilateral breast cancer and woman with both breast and ovarian cancer count as single individual and 1 woman must be first-degree relative of the other two, or related to the other two through a male and at least 1 woman affected with breast cancer before age 50 or ovarian cancer at any age
Beschrijving

Patient affected | First Degree Relative Affected | Hereditary Breast and Ovarian Cancer Syndrome Test | Hereditary Breast and Ovarian Cancer Syndrome Test Negative | Breast Cancer, hereditary | Ovarian Carcinoma Hereditary | bilateral breast cancer | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0522476
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C0392760
UMLS CUI [3,1]
C0677776
UMLS CUI [3,2]
C0392366
UMLS CUI [4,1]
C0677776
UMLS CUI [4,2]
C0392366
UMLS CUI [4,3]
C0205160
UMLS CUI [5]
C0346153
UMLS CUI [6,1]
C0029925
UMLS CUI [6,2]
C0439660
UMLS CUI [7]
C0281267
UMLS CUI [8]
C0001779
able to understand and complete english-language questionnaires
Beschrijving

Comprehension English Language Questionnaire | Completion English Language Questionnaire

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0034394
UMLS CUI [2,1]
C0205197
UMLS CUI [2,2]
C0376245
UMLS CUI [2,3]
C0034394
intend to receive clinical and radiographic follow-up at mskcc
Beschrijving

Clinical Study Follow-up Willing | Follow-up Radiographic Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0444708
UMLS CUI [2,3]
C0600109
women will not be excluded if they have previously received clinical and radiographic follow-up at either mskcc or another institution.
Beschrijving

Clinical Study Follow-up | Follow-up Radiographic

Datatype

boolean

Alias
UMLS CUI [1]
C3274571
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0444708
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of breast or ovarian cancer
Beschrijving

Breast Carcinoma | Ovarian Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0029925
contraindication to breast mri examination (e.g. aneurysm clips, pacemaker, cochlear implant, severe claustrophobia, weight over 300 pounds) or to paramagnetic contrast (prior ige-type allergic reaction, sickle cell anemia, renal failure)
Beschrijving

Medical contraindication Magnetic resonance imaging of breast | Aneurysm clip | Artificial cardiac pacemaker | Cochlear Implants | Claustrophobia Severe | Body Weight | Medical contraindication Paramagnetic Contrast Agent | IgE-mediated hypersensitivity | Anemia, Sickle Cell | Kidney Failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0344104
UMLS CUI [2]
C0179977
UMLS CUI [3]
C0030163
UMLS CUI [4]
C0009199
UMLS CUI [5,1]
C0008909
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0005910
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C2917410
UMLS CUI [8]
C0020523
UMLS CUI [9]
C0002895
UMLS CUI [10]
C0035078
pregnant or planning to begin attempts at conception within 1 year of enrollment. a negative serum β-hcg will not be required for study entry, nor for radiographic examination, as this test is not routinely performed before clinically indicated radiographic study.
Beschrijving

Pregnancy | Pregnancy, Planned | Serum Beta-HCG Test Negative | radiologic examination

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C1255526
UMLS CUI [3,2]
C0205160
UMLS CUI [4]
C0043299
unable for physical, psychological, or financial reasons to receive clinical and radiographic follow-up at mskcc
Beschrijving

Clinical Study Follow-up Unable | Follow-up Radiographic Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0444708
UMLS CUI [2,3]
C1299582
concurrent medical or psychological conditions that, in the opinion of the attending physician or principal investigator, would place the subject at risk were she to participate
Beschrijving

Comorbidity Study Subject Participation Status Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
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Similar models

Eligibility Breast Cancer NCT00582803

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 25 years or greater
boolean
C0001779 (UMLS CUI [1])
Genetic Predisposition
Item
genetic predisposition as defined by one of the following:
boolean
C0314657 (UMLS CUI [1])
BRCA1 gene mutation Deleterious | BRCA2 gene mutation Deleterious | BRCA1 gene mutation Significance undetermined | BRCA2 gene mutation Significance undetermined
Item
known brca1 or brca2 mutation (deleterious or uncertain significance) or
boolean
C1511022 (UMLS CUI [1,1])
C2985436 (UMLS CUI [1,2])
C1511024 (UMLS CUI [2,1])
C2985436 (UMLS CUI [2,2])
C1511022 (UMLS CUI [3,1])
C1272585 (UMLS CUI [3,2])
C1511024 (UMLS CUI [4,1])
C1272585 (UMLS CUI [4,2])
brca gene Deleterious Mutation | First Degree Relative Tested
Item
untested first-degree relative of an individual with a known deleterious brca mutation or
boolean
C0596223 (UMLS CUI [1,1])
C2985436 (UMLS CUI [1,2])
C1517194 (UMLS CUI [2,1])
C0392366 (UMLS CUI [2,2])
Patient affected | First Degree Relative Affected | Hereditary Breast and Ovarian Cancer Syndrome Test | Hereditary Breast and Ovarian Cancer Syndrome Test Negative | Breast Cancer, hereditary | Ovarian Carcinoma Hereditary | bilateral breast cancer | Age
Item
unaffected first-degree relative of an affected individual within a hereditary breast-ovarian kindred in which no testing has been performed or testing is negative, defined as: 3 or more women in 2 generations affected with breast or ovarian cancer. women with bilateral breast cancer and woman with both breast and ovarian cancer count as single individual and 1 woman must be first-degree relative of the other two, or related to the other two through a male and at least 1 woman affected with breast cancer before age 50 or ovarian cancer at any age
boolean
C0522476 (UMLS CUI [1])
C1517194 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0677776 (UMLS CUI [3,1])
C0392366 (UMLS CUI [3,2])
C0677776 (UMLS CUI [4,1])
C0392366 (UMLS CUI [4,2])
C0205160 (UMLS CUI [4,3])
C0346153 (UMLS CUI [5])
C0029925 (UMLS CUI [6,1])
C0439660 (UMLS CUI [6,2])
C0281267 (UMLS CUI [7])
C0001779 (UMLS CUI [8])
Comprehension English Language Questionnaire | Completion English Language Questionnaire
Item
able to understand and complete english-language questionnaires
boolean
C0162340 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,3])
C0205197 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0034394 (UMLS CUI [2,3])
Clinical Study Follow-up Willing | Follow-up Radiographic Willing
Item
intend to receive clinical and radiographic follow-up at mskcc
boolean
C3274571 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0444708 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Clinical Study Follow-up | Follow-up Radiographic
Item
women will not be excluded if they have previously received clinical and radiographic follow-up at either mskcc or another institution.
boolean
C3274571 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C0444708 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma | Ovarian Carcinoma
Item
prior history of breast or ovarian cancer
boolean
C0678222 (UMLS CUI [1])
C0029925 (UMLS CUI [2])
Medical contraindication Magnetic resonance imaging of breast | Aneurysm clip | Artificial cardiac pacemaker | Cochlear Implants | Claustrophobia Severe | Body Weight | Medical contraindication Paramagnetic Contrast Agent | IgE-mediated hypersensitivity | Anemia, Sickle Cell | Kidney Failure
Item
contraindication to breast mri examination (e.g. aneurysm clips, pacemaker, cochlear implant, severe claustrophobia, weight over 300 pounds) or to paramagnetic contrast (prior ige-type allergic reaction, sickle cell anemia, renal failure)
boolean
C1301624 (UMLS CUI [1,1])
C0344104 (UMLS CUI [1,2])
C0179977 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
C0009199 (UMLS CUI [4])
C0008909 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0005910 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C2917410 (UMLS CUI [7,2])
C0020523 (UMLS CUI [8])
C0002895 (UMLS CUI [9])
C0035078 (UMLS CUI [10])
Pregnancy | Pregnancy, Planned | Serum Beta-HCG Test Negative | radiologic examination
Item
pregnant or planning to begin attempts at conception within 1 year of enrollment. a negative serum β-hcg will not be required for study entry, nor for radiographic examination, as this test is not routinely performed before clinically indicated radiographic study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C1255526 (UMLS CUI [3,1])
C0205160 (UMLS CUI [3,2])
C0043299 (UMLS CUI [4])
Clinical Study Follow-up Unable | Follow-up Radiographic Unable
Item
unable for physical, psychological, or financial reasons to receive clinical and radiographic follow-up at mskcc
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0444708 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Comorbidity Study Subject Participation Status Limited
Item
concurrent medical or psychological conditions that, in the opinion of the attending physician or principal investigator, would place the subject at risk were she to participate
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
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