ID

38219

Descripción

Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing; ODM derived from: https://clinicaltrials.gov/show/NCT01992471

Link

https://clinicaltrials.gov/show/NCT01992471

Palabras clave

Versiones (1)
  1. 29/9/19 29/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de septiembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01992471

Inglés

Eligibility Breast Cancer NCT01992471

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female age 18 or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
personal history of breast cancer and one of the following:
Descripción

Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678222
invasive breast cancer or dcis diagnosed at or before age 45 invasive breast cancer diagnosed at/before age 50 with one or more of the following:
Descripción

Invasive carcinoma of breast | DCIS | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0001779
limited family history (fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. the "limited family history" can occur on either the maternal or paternal side of the family.)
Descripción

Family history Limited | First Degree Relative Gender Quantity | Second Degree Relative Gender Quantity | Lifetime Age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C0079399
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1519210
UMLS CUI [3,2]
C0079399
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C4071830
UMLS CUI [4,2]
C0001779
1 or more first-/second-degree relatives with invasive bc at/before 50
Descripción

First Degree Relative Quantity | Second Degree Relative Quantity | Invasive carcinoma of breast | Age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1519210
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0853879
UMLS CUI [4]
C0001779
1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age)
Descripción

First Degree Relative Quantity | Second Degree Relative Quantity | Epithelial ovarian cancer Invasive | Age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1519210
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0677886
UMLS CUI [3,2]
C0205281
UMLS CUI [4]
C0001779
1 or more first- or second-degree relatives with male breast cancer
Descripción

First Degree Relative Quantity | Second Degree Relative Quantity | Carcinoma of Male Breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1519210
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0238033
2 or more first- or second-degree relatives with pancreas cancer
Descripción

First Degree Relative Quantity | Second Degree Relative Quantity | Pancreatic carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1519210
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0235974
invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer.
Descripción

Invasive carcinoma of breast | Age | First Degree Relative Quantity Affected Invasive carcinoma of breast | Second Degree Relative Quantity Affected Invasive carcinoma of breast | First Degree Relative Quantity Affected Epithelial ovarian cancer Invasive | Second Degree Relative Quantity Affected Epithelial ovarian cancer Invasive | First Degree Relative Quantity Affected Carcinoma of Male Breast | Second Degree Relative Quantity Affected Carcinoma of Male Breast | First Degree Relative Quantity Affected Pancreatic carcinoma | Second Degree Relative Quantity Affected Pancreatic carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1517194
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0392760
UMLS CUI [3,4]
C0853879
UMLS CUI [4,1]
C1519210
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0853879
UMLS CUI [5,1]
C1517194
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0392760
UMLS CUI [5,4]
C0677886
UMLS CUI [5,5]
C0205281
UMLS CUI [6,1]
C1519210
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0392760
UMLS CUI [6,4]
C0677886
UMLS CUI [6,5]
C0205281
UMLS CUI [7,1]
C1517194
UMLS CUI [7,2]
C1265611
UMLS CUI [7,3]
C0392760
UMLS CUI [7,4]
C0238033
UMLS CUI [8,1]
C1519210
UMLS CUI [8,2]
C1265611
UMLS CUI [8,3]
C0392760
UMLS CUI [8,4]
C0238033
UMLS CUI [9,1]
C1517194
UMLS CUI [9,2]
C1265611
UMLS CUI [9,3]
C0392760
UMLS CUI [9,4]
C0235974
UMLS CUI [10,1]
C1519210
UMLS CUI [10,2]
C1265611
UMLS CUI [10,3]
C0392760
UMLS CUI [10,4]
C0235974
full sequence brca1 and brca2 testing completed with no deleterious mutation identified.
Descripción

Full sequence analysis of BRCA2 together with BRCA1 | Deleterious Mutation Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3251008
UMLS CUI [2,1]
C2985436
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to provide informed consent for testing
Descripción

Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
unable to complete english language questionnaire
Descripción

Questionnaire English Language Completion Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
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Similar models

Eligibility Breast Cancer NCT01992471

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female age 18 or older
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma
Item
personal history of breast cancer and one of the following:
boolean
C0678222 (UMLS CUI [1])
Invasive carcinoma of breast | DCIS | Age
Item
invasive breast cancer or dcis diagnosed at or before age 45 invasive breast cancer diagnosed at/before age 50 with one or more of the following:
boolean
C0853879 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Family history Limited | First Degree Relative Gender Quantity | Second Degree Relative Gender Quantity | Lifetime Age
Item
limited family history (fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. the "limited family history" can occur on either the maternal or paternal side of the family.)
boolean
C0241889 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1517194 (UMLS CUI [2,1])
C0079399 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1519210 (UMLS CUI [3,1])
C0079399 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C4071830 (UMLS CUI [4,1])
C0001779 (UMLS CUI [4,2])
First Degree Relative Quantity | Second Degree Relative Quantity | Invasive carcinoma of breast | Age
Item
1 or more first-/second-degree relatives with invasive bc at/before 50
boolean
C1517194 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1519210 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0853879 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
First Degree Relative Quantity | Second Degree Relative Quantity | Epithelial ovarian cancer Invasive | Age
Item
1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age)
boolean
C1517194 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1519210 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0677886 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
First Degree Relative Quantity | Second Degree Relative Quantity | Carcinoma of Male Breast
Item
1 or more first- or second-degree relatives with male breast cancer
boolean
C1517194 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1519210 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0238033 (UMLS CUI [3])
First Degree Relative Quantity | Second Degree Relative Quantity | Pancreatic carcinoma
Item
2 or more first- or second-degree relatives with pancreas cancer
boolean
C1517194 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1519210 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0235974 (UMLS CUI [3])
Invasive carcinoma of breast | Age | First Degree Relative Quantity Affected Invasive carcinoma of breast | Second Degree Relative Quantity Affected Invasive carcinoma of breast | First Degree Relative Quantity Affected Epithelial ovarian cancer Invasive | Second Degree Relative Quantity Affected Epithelial ovarian cancer Invasive | First Degree Relative Quantity Affected Carcinoma of Male Breast | Second Degree Relative Quantity Affected Carcinoma of Male Breast | First Degree Relative Quantity Affected Pancreatic carcinoma | Second Degree Relative Quantity Affected Pancreatic carcinoma
Item
invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer.
boolean
C0853879 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1517194 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0853879 (UMLS CUI [3,4])
C1519210 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0853879 (UMLS CUI [4,4])
C1517194 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0392760 (UMLS CUI [5,3])
C0677886 (UMLS CUI [5,4])
C0205281 (UMLS CUI [5,5])
C1519210 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0392760 (UMLS CUI [6,3])
C0677886 (UMLS CUI [6,4])
C0205281 (UMLS CUI [6,5])
C1517194 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0392760 (UMLS CUI [7,3])
C0238033 (UMLS CUI [7,4])
C1519210 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C0392760 (UMLS CUI [8,3])
C0238033 (UMLS CUI [8,4])
C1517194 (UMLS CUI [9,1])
C1265611 (UMLS CUI [9,2])
C0392760 (UMLS CUI [9,3])
C0235974 (UMLS CUI [9,4])
C1519210 (UMLS CUI [10,1])
C1265611 (UMLS CUI [10,2])
C0392760 (UMLS CUI [10,3])
C0235974 (UMLS CUI [10,4])
Full sequence analysis of BRCA2 together with BRCA1 | Deleterious Mutation Absent
Item
full sequence brca1 and brca2 testing completed with no deleterious mutation identified.
boolean
C3251008 (UMLS CUI [1])
C2985436 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
unable to provide informed consent for testing
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Questionnaire English Language Completion Unable
Item
unable to complete english language questionnaire
boolean
C0034394 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
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