ID

37734

Beschrijving

Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS); ODM derived from: https://clinicaltrials.gov/show/NCT00500383

Link

https://clinicaltrials.gov/show/NCT00500383

Trefwoorden

Versies (1)
  1. 20-08-19 20-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00500383

Engels

Eligibility Breast Cancer NCT00500383

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
brca carriers (cases)
Beschrijving

BRCA Carrier | Case

Datatype

boolean

Alias
UMLS CUI [1,1]
C0596223
UMLS CUI [1,2]
C0007294
UMLS CUI [2]
C1706256
attending one of the three participating high-risk screening centres
Beschrijving

High risk Screening Attending clinic

Datatype

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C1710032
UMLS CUI [1,3]
C0730261
confirmed brca1 or brca2 mutation status through genetic testing
Beschrijving

BRCA1 gene mutation Status Genetic screening method | BRCA2 gene mutation Status Genetic screening method

Datatype

boolean

Alias
UMLS CUI [1,1]
C1511022
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0679560
UMLS CUI [2,1]
C1511024
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0679560
high-risk (cases)
Beschrijving

High risk | Case

Datatype

boolean

Alias
UMLS CUI [1]
C4319571
UMLS CUI [2]
C1706256
attending one of the three participating high-risk screening centres
Beschrijving

High risk Screening Attending clinic

Datatype

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C1710032
UMLS CUI [1,3]
C0730261
confirmed negative brca1/2 status through genetic testing
Beschrijving

BRCA1 gene mutation negative | BRCA2 gene mutation negative

Datatype

boolean

Alias
UMLS CUI [1]
C1445907
UMLS CUI [2]
C1445910
brca non-carriers (controls)
Beschrijving

BRCA Noncarrier | Control Groups

Datatype

boolean

Alias
UMLS CUI [1,1]
C0596223
UMLS CUI [1,2]
C2986416
UMLS CUI [2]
C0009932
attain a gail model score of <1.1 and have <10% risk of carrying the brca mutation determined by the penn ii model)
Beschrijving

Gail risk model | Risk Percentage BRCA Mutation | Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C1511297
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0596223
UMLS CUI [2,4]
C0026882
UMLS CUI [3]
C3846158
controls from high-risk screening centre with confirmed brca1/2 negative status through genetic testing
Beschrijving

Control Groups | High risk Screening Attending clinic | BRCA1 gene mutation negative | BRCA2 gene mutation negative

Datatype

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C1710032
UMLS CUI [2,3]
C0730261
UMLS CUI [3]
C1445907
UMLS CUI [4]
C1445910
preference will be given to sisters or first degree cousins of brca carriers
Beschrijving

Sister BRCA Carrier | First cousin BRCA Carrier

Datatype

boolean

Alias
UMLS CUI [1,1]
C0337514
UMLS CUI [1,2]
C0596223
UMLS CUI [1,3]
C0007294
UMLS CUI [2,1]
C0337583
UMLS CUI [2,2]
C0596223
UMLS CUI [2,3]
C0007294
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
cases and controls
Beschrijving

Case | Control Groups

Datatype

boolean

Alias
UMLS CUI [1]
C1706256
UMLS CUI [2]
C0009932
prior diagnosis or breast or ovarian cancer
Beschrijving

Prior diagnosis Breast Carcinoma | Prior diagnosis Ovarian Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C0029925
bilateral biopsy or fine needle aspiration within 1 year of study start
Beschrijving

Biopsy Bilateral | Fine needle aspiration Bilateral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C1510483
UMLS CUI [2,2]
C0238767
bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation)
Beschrijving

Bilateral mastectomy | Lumpectomy of breast | Alteration Cosmetic procedure | Cosmetic breast reduction | Cosmetic breast augmentation

Datatype

boolean

Alias
UMLS CUI [1]
C0191877
UMLS CUI [2]
C0851238
UMLS CUI [3,1]
C1515926
UMLS CUI [3,2]
C0442965
UMLS CUI [4]
C1390445
UMLS CUI [5]
C1390444
previous or current chemotherapy or prevention therapy (tamoxifen)
Beschrijving

Chemotherapy | Prophylactic treatment | Tamoxifen

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0199176
UMLS CUI [3]
C0039286
less than 3 years post pregnancy at study start
Beschrijving

Pregnancy Recently

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332185
inability to provide informed consent due to language or cognitive difficulties
Beschrijving

Informed Consent Unable | Language problems | Impaired cognition

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C1405458
UMLS CUI [3]
C0338656
*for controls only
Beschrijving

Control Groups

Datatype

boolean

Alias
UMLS CUI [1]
C0009932
family history of breast cancer where family member had an early diagnosis (before age 45 years)
Beschrijving

Family history of breast cancer | Family member Early Diagnosis | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0559119
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C0596473
UMLS CUI [3]
C0001779
family history or ovarian cancer
Beschrijving

Family history Ovarian neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0919267
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Similar models

Eligibility Breast Cancer NCT00500383

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
BRCA Carrier | Case
Item
brca carriers (cases)
boolean
C0596223 (UMLS CUI [1,1])
C0007294 (UMLS CUI [1,2])
C1706256 (UMLS CUI [2])
High risk Screening Attending clinic
Item
attending one of the three participating high-risk screening centres
boolean
C4319571 (UMLS CUI [1,1])
C1710032 (UMLS CUI [1,2])
C0730261 (UMLS CUI [1,3])
BRCA1 gene mutation Status Genetic screening method | BRCA2 gene mutation Status Genetic screening method
Item
confirmed brca1 or brca2 mutation status through genetic testing
boolean
C1511022 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0679560 (UMLS CUI [1,3])
C1511024 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0679560 (UMLS CUI [2,3])
High risk | Case
Item
high-risk (cases)
boolean
C4319571 (UMLS CUI [1])
C1706256 (UMLS CUI [2])
High risk Screening Attending clinic
Item
attending one of the three participating high-risk screening centres
boolean
C4319571 (UMLS CUI [1,1])
C1710032 (UMLS CUI [1,2])
C0730261 (UMLS CUI [1,3])
BRCA1 gene mutation negative | BRCA2 gene mutation negative
Item
confirmed negative brca1/2 status through genetic testing
boolean
C1445907 (UMLS CUI [1])
C1445910 (UMLS CUI [2])
BRCA Noncarrier | Control Groups
Item
brca non-carriers (controls)
boolean
C0596223 (UMLS CUI [1,1])
C2986416 (UMLS CUI [1,2])
C0009932 (UMLS CUI [2])
Gail risk model | Risk Percentage BRCA Mutation | Other Coding
Item
attain a gail model score of <1.1 and have <10% risk of carrying the brca mutation determined by the penn ii model)
boolean
C1511297 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0596223 (UMLS CUI [2,3])
C0026882 (UMLS CUI [2,4])
C3846158 (UMLS CUI [3])
Control Groups | High risk Screening Attending clinic | BRCA1 gene mutation negative | BRCA2 gene mutation negative
Item
controls from high-risk screening centre with confirmed brca1/2 negative status through genetic testing
boolean
C0009932 (UMLS CUI [1])
C4319571 (UMLS CUI [2,1])
C1710032 (UMLS CUI [2,2])
C0730261 (UMLS CUI [2,3])
C1445907 (UMLS CUI [3])
C1445910 (UMLS CUI [4])
Sister BRCA Carrier | First cousin BRCA Carrier
Item
preference will be given to sisters or first degree cousins of brca carriers
boolean
C0337514 (UMLS CUI [1,1])
C0596223 (UMLS CUI [1,2])
C0007294 (UMLS CUI [1,3])
C0337583 (UMLS CUI [2,1])
C0596223 (UMLS CUI [2,2])
C0007294 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Case | Control Groups
Item
cases and controls
boolean
C1706256 (UMLS CUI [1])
C0009932 (UMLS CUI [2])
Prior diagnosis Breast Carcinoma | Prior diagnosis Ovarian Carcinoma
Item
prior diagnosis or breast or ovarian cancer
boolean
C0332132 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0029925 (UMLS CUI [2,2])
Biopsy Bilateral | Fine needle aspiration Bilateral
Item
bilateral biopsy or fine needle aspiration within 1 year of study start
boolean
C0005558 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C1510483 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
Bilateral mastectomy | Lumpectomy of breast | Alteration Cosmetic procedure | Cosmetic breast reduction | Cosmetic breast augmentation
Item
bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation)
boolean
C0191877 (UMLS CUI [1])
C0851238 (UMLS CUI [2])
C1515926 (UMLS CUI [3,1])
C0442965 (UMLS CUI [3,2])
C1390445 (UMLS CUI [4])
C1390444 (UMLS CUI [5])
Chemotherapy | Prophylactic treatment | Tamoxifen
Item
previous or current chemotherapy or prevention therapy (tamoxifen)
boolean
C0392920 (UMLS CUI [1])
C0199176 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
Pregnancy Recently
Item
less than 3 years post pregnancy at study start
boolean
C0032961 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Informed Consent Unable | Language problems | Impaired cognition
Item
inability to provide informed consent due to language or cognitive difficulties
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1405458 (UMLS CUI [2])
C0338656 (UMLS CUI [3])
Control Groups
Item
*for controls only
boolean
C0009932 (UMLS CUI [1])
Family history of breast cancer | Family member Early Diagnosis | Age
Item
family history of breast cancer where family member had an early diagnosis (before age 45 years)
boolean
C0559119 (UMLS CUI [1])
C0086282 (UMLS CUI [2,1])
C0596473 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Family history Ovarian neoplasm
Item
family history or ovarian cancer
boolean
C0241889 (UMLS CUI [1,1])
C0919267 (UMLS CUI [1,2])
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