ID

38210

Description

Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry; ODM derived from: https://clinicaltrials.gov/show/NCT02302742

Link

https://clinicaltrials.gov/show/NCT02302742

Keywords

Versions (1)
  1. 9/27/19 9/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02302742

English

Eligibility Breast Cancer NCT02302742

1 forms  
Criteria
Description

Criteria

triple negative breast cancer
Description

Triple Negative Breast Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C3539878
er/pr <10% and her negative per current asco/cap guidelines
Description

Estrogen Receptors Percentage | Progesterone Receptors Percentage | Human epidermal growth factor receptor negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0034804
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0034833
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C4087185
stages i-iv
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
any age at diagnosis
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient must be within 5 years of diagnosis
Description

Diagnosis Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0872291
eligible regardless of genetic testing status
Description

Patient eligible for clinical trial Independent of Genetic testing

Data type

boolean

Alias
UMLS CUI [1,1]
C1302261
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0679560
genetic testing recommended for patients meeting nccn and medicare guidelines
Description

Genetic testing Recommended

Data type

boolean

Alias
UMLS CUI [1,1]
C0679560
UMLS CUI [1,2]
C0034866
and/or
Description

ID.8

Data type

boolean

germline mutation carriers
Description

Germ-Line Mutation Carrier

Data type

boolean

Alias
UMLS CUI [1,1]
C0206530
UMLS CUI [1,2]
C2985478
patients with deleterious or uncertain mutations in hboc genes (brca, pten, p53,-palb2 etc) are eligible regardless of type/site of cancer
Description

HBOC Genes | BRCA gene | PTEN gene | TP53 gene | PALB2 gene | Patient eligible for clinical trial Independent of Cancer site

Data type

boolean

Alias
UMLS CUI [1,1]
C0677776
UMLS CUI [1,2]
C0017337
UMLS CUI [2]
C0596223
UMLS CUI [3]
C0694888
UMLS CUI [4]
C0079419
UMLS CUI [5]
C1835898
UMLS CUI [6,1]
C1302261
UMLS CUI [6,2]
C0332291
UMLS CUI [6,3]
C0872338
healthy patients harboring mutations also eligible
Description

Healthy Volunteers Mutation | Patient eligible for clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0026882
UMLS CUI [2]
C1302261
there is no time limit from the time of diagnosis of cancer and enrollment.
Description

Time limit Absent | Cancer diagnosis | Enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0332186
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0920688
UMLS CUI [3]
C1516879
eligible regardless of personal history of cancer
Description

Patient eligible for clinical trial Independent of Cancer History

Data type

boolean

Alias
UMLS CUI [1,1]
C1302261
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C1512706
exclusion criteria include:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
triple negative breast cancer -patient is not within five years of diagnosis
Description

Triple Negative Breast Neoplasm Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C0205156
germline mutation carriers:
Description

Germ-Line Mutation Carrier

Data type

boolean

Alias
UMLS CUI [1,1]
C0206530
UMLS CUI [1,2]
C2985478
patient only carries a hboc mutation that is classified as "polymorphism" of "favor polymorphism"
Description

HBOC Mutation Singular | Polymorphism

Data type

boolean

Alias
UMLS CUI [1,1]
C0677776
UMLS CUI [1,2]
C0026882
UMLS CUI [1,3]
C0205171
UMLS CUI [2]
C1882417
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Similar models

Eligibility Breast Cancer NCT02302742

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Triple Negative Breast Neoplasms
Item
triple negative breast cancer
boolean
C3539878 (UMLS CUI [1])
Estrogen Receptors Percentage | Progesterone Receptors Percentage | Human epidermal growth factor receptor negative
Item
er/pr <10% and her negative per current asco/cap guidelines
boolean
C0034804 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0034833 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C4087185 (UMLS CUI [3])
TNM Breast tumor staging
Item
stages i-iv
boolean
C0474926 (UMLS CUI [1])
Age
Item
any age at diagnosis
boolean
C0001779 (UMLS CUI [1])
Diagnosis Timespan
Item
patient must be within 5 years of diagnosis
boolean
C0011900 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
Patient eligible for clinical trial Independent of Genetic testing
Item
eligible regardless of genetic testing status
boolean
C1302261 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0679560 (UMLS CUI [1,3])
Genetic testing Recommended
Item
genetic testing recommended for patients meeting nccn and medicare guidelines
boolean
C0679560 (UMLS CUI [1,1])
C0034866 (UMLS CUI [1,2])
ID.8
Item
and/or
boolean
Germ-Line Mutation Carrier
Item
germline mutation carriers
boolean
C0206530 (UMLS CUI [1,1])
C2985478 (UMLS CUI [1,2])
HBOC Genes | BRCA gene | PTEN gene | TP53 gene | PALB2 gene | Patient eligible for clinical trial Independent of Cancer site
Item
patients with deleterious or uncertain mutations in hboc genes (brca, pten, p53,-palb2 etc) are eligible regardless of type/site of cancer
boolean
C0677776 (UMLS CUI [1,1])
C0017337 (UMLS CUI [1,2])
C0596223 (UMLS CUI [2])
C0694888 (UMLS CUI [3])
C0079419 (UMLS CUI [4])
C1835898 (UMLS CUI [5])
C1302261 (UMLS CUI [6,1])
C0332291 (UMLS CUI [6,2])
C0872338 (UMLS CUI [6,3])
Healthy Volunteers Mutation | Patient eligible for clinical trial
Item
healthy patients harboring mutations also eligible
boolean
C1708335 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C1302261 (UMLS CUI [2])
Time limit Absent | Cancer diagnosis | Enrollment
Item
there is no time limit from the time of diagnosis of cancer and enrollment.
boolean
C0332186 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0920688 (UMLS CUI [2])
C1516879 (UMLS CUI [3])
Patient eligible for clinical trial Independent of Cancer History
Item
eligible regardless of personal history of cancer
boolean
C1302261 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C1512706 (UMLS CUI [1,3])
Exclusion Criteria
Item
exclusion criteria include:
boolean
C0680251 (UMLS CUI [1])
Triple Negative Breast Neoplasm Previous
Item
triple negative breast cancer -patient is not within five years of diagnosis
boolean
C3539878 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Germ-Line Mutation Carrier
Item
germline mutation carriers:
boolean
C0206530 (UMLS CUI [1,1])
C2985478 (UMLS CUI [1,2])
HBOC Mutation Singular | Polymorphism
Item
patient only carries a hboc mutation that is classified as "polymorphism" of "favor polymorphism"
boolean
C0677776 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C1882417 (UMLS CUI [2])
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