ID

19641

Description

Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts; ODM derived from: https://clinicaltrials.gov/show/NCT00620373

Lien

https://clinicaltrials.gov/show/NCT00620373

Mots-clés

Versions (1)
  1. 18/01/2017 18/01/2017 -
Téléchargé le

18 janvier 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00620373

Anglais

Eligibility Breast Cancer NCT00620373

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. past prior screening mammography (sm) interpreted as negative or benign (this screening must have been performed at mayo clinic rochester, minnesota).
Description

Screening mammography Interpreted Negative | Screening mammography Interpreted Benign

Type de données

boolean

Alias
UMLS CUI [1,1]
C0203028
UMLS CUI [1,2]
C1285553
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0203028
UMLS CUI [2,2]
C1285553
UMLS CUI [2,3]
C0205183
2. past prior sm interpreted as heterogeneously dense or extremely dense (this screening must have been performed at mayo clinic rochester, minnesota).
Description

Screening mammography Interpreted Heterogeneously dense | Screening mammography Interpreted Extremely dense

Type de données

boolean

Alias
UMLS CUI [1,1]
C0203028
UMLS CUI [1,2]
C1285553
UMLS CUI [1,3]
C1268646
UMLS CUI [2,1]
C0203028
UMLS CUI [2,2]
C1285553
UMLS CUI [2,3]
C1268647
3. women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.
Description

Gender Mammography Lacking | Age | Gender Dense connective tissue of breast

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0024671
UMLS CUI [1,3]
C0332268
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C1179021
4. subjects had to have at least one of the following risk factors:
Description

risk factors

Type de données

boolean

Alias
UMLS CUI [1]
C0035648
1. known mutation in breast cancer susceptibility gene 1 (brca1) or breast cancer susceptibility gene 2 (brca2)
Description

BRCA1 gene mutation | BRCA2 gene mutation

Type de données

boolean

Alias
UMLS CUI [1]
C1511022
UMLS CUI [2]
C1511024
2. history of chest, mediastinal, or axillary irradiation
Description

irradiation of chest wall | irradiation of mediastinum | irradiation of axillary lymph nodes

Type de données

boolean

Alias
UMLS CUI [1]
C2064934
UMLS CUI [2]
C2152905
UMLS CUI [3]
C2169036
3. personal history of breast cancer
Description

Breast Carcinoma Personal History

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0262926
4. history of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma
Description

Atypical ductal hyperplasia Biopsy | Atypical lobular hyperplasia Biopsy | Lobular carcinoma in situ Biopsy | Atypical Breast Papilloma Biopsy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442834
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0442835
UMLS CUI [2,2]
C0005558
UMLS CUI [3,1]
C0334381
UMLS CUI [3,2]
C0005558
UMLS CUI [4,1]
C1332346
UMLS CUI [4,2]
C0005558
5. gail or claus model lifetime risk greater than or equal to 20%
Description

Lifetime Risk Percentage Gail Risk Model | Lifetime Risk Percentage Claus Model

Type de données

boolean

Alias
UMLS CUI [1,1]
C1517878
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1511297
UMLS CUI [2,1]
C1517878
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C1707405
6. gail model 5 year risk greater or equal to 2.5%
Description

Risk Timespan Percentage Gail Risk Model

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0872291
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C1511297
7. gail model 5 year risk greater or equal to 1.6%
Description

Risk Timespan Percentage Gail Risk Model

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0872291
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C1511297
8. one first-degree relative with history of breast cancer
Description

Breast Carcinoma First Degree Relative Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1517194
UMLS CUI [1,3]
C1265611
9. two second-degree relatives with history of breast cancer
Description

Breast Carcinoma Second Degree Relative Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1519210
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. they are unable to understand and sign the consent form
Description

Informed Consent Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. they are pregnant or lactating
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. they are physically unable to sit upright and still for 40 minutes.
Description

Able to sit up Quiet Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0560835
UMLS CUI [1,2]
C0439654
UMLS CUI [1,3]
C0449238
4. they have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).
Description

Breast Carcinoma Sign or Symptom | Palpable mass | Bloody nipple discharge | Mass of axilla

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3540840
UMLS CUI [2]
C0746412
UMLS CUI [3]
C0541951
UMLS CUI [4]
C0238729
5. they have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.
Description

Needle biopsy | Operation on breast

Type de données

boolean

Alias
UMLS CUI [1]
C0005560
UMLS CUI [2]
C3714726
6. they are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.
Description

Adjuvant therapy | Chemoprevention | Tamoxifen | Evista | Raloxifene | Aromatase Inhibitors

Type de données

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2]
C0282515
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0720318
UMLS CUI [5]
C0244404
UMLS CUI [6]
C0593802
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Similar models

Eligibility Breast Cancer NCT00620373

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Screening mammography Interpreted Negative | Screening mammography Interpreted Benign
Item
1. past prior screening mammography (sm) interpreted as negative or benign (this screening must have been performed at mayo clinic rochester, minnesota).
boolean
C0203028 (UMLS CUI [1,1])
C1285553 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0203028 (UMLS CUI [2,1])
C1285553 (UMLS CUI [2,2])
C0205183 (UMLS CUI [2,3])
Screening mammography Interpreted Heterogeneously dense | Screening mammography Interpreted Extremely dense
Item
2. past prior sm interpreted as heterogeneously dense or extremely dense (this screening must have been performed at mayo clinic rochester, minnesota).
boolean
C0203028 (UMLS CUI [1,1])
C1285553 (UMLS CUI [1,2])
C1268646 (UMLS CUI [1,3])
C0203028 (UMLS CUI [2,1])
C1285553 (UMLS CUI [2,2])
C1268647 (UMLS CUI [2,3])
Gender Mammography Lacking | Age | Gender Dense connective tissue of breast
Item
3. women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.
boolean
C0079399 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C1179021 (UMLS CUI [3,2])
risk factors
Item
4. subjects had to have at least one of the following risk factors:
boolean
C0035648 (UMLS CUI [1])
BRCA1 gene mutation | BRCA2 gene mutation
Item
1. known mutation in breast cancer susceptibility gene 1 (brca1) or breast cancer susceptibility gene 2 (brca2)
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
irradiation of chest wall | irradiation of mediastinum | irradiation of axillary lymph nodes
Item
2. history of chest, mediastinal, or axillary irradiation
boolean
C2064934 (UMLS CUI [1])
C2152905 (UMLS CUI [2])
C2169036 (UMLS CUI [3])
Breast Carcinoma Personal History
Item
3. personal history of breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Atypical ductal hyperplasia Biopsy | Atypical lobular hyperplasia Biopsy | Lobular carcinoma in situ Biopsy | Atypical Breast Papilloma Biopsy
Item
4. history of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma
boolean
C0442834 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0442835 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0334381 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C1332346 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
Lifetime Risk Percentage Gail Risk Model | Lifetime Risk Percentage Claus Model
Item
5. gail or claus model lifetime risk greater than or equal to 20%
boolean
C1517878 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1511297 (UMLS CUI [1,3])
C1517878 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1707405 (UMLS CUI [2,3])
Risk Timespan Percentage Gail Risk Model
Item
6. gail model 5 year risk greater or equal to 2.5%
boolean
C0035647 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1511297 (UMLS CUI [1,4])
Risk Timespan Percentage Gail Risk Model
Item
7. gail model 5 year risk greater or equal to 1.6%
boolean
C0035647 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1511297 (UMLS CUI [1,4])
Breast Carcinoma First Degree Relative Quantity
Item
8. one first-degree relative with history of breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Breast Carcinoma Second Degree Relative Quantity
Item
9. two second-degree relatives with history of breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1519210 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
1. they are unable to understand and sign the consent form
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
2. they are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Able to sit up Quiet Duration
Item
3. they are physically unable to sit upright and still for 40 minutes.
boolean
C0560835 (UMLS CUI [1,1])
C0439654 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Breast Carcinoma Sign or Symptom | Palpable mass | Bloody nipple discharge | Mass of axilla
Item
4. they have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).
boolean
C0678222 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C0746412 (UMLS CUI [2])
C0541951 (UMLS CUI [3])
C0238729 (UMLS CUI [4])
Needle biopsy | Operation on breast
Item
5. they have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.
boolean
C0005560 (UMLS CUI [1])
C3714726 (UMLS CUI [2])
Adjuvant therapy | Chemoprevention | Tamoxifen | Evista | Raloxifene | Aromatase Inhibitors
Item
6. they are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.
boolean
C0677850 (UMLS CUI [1])
C0282515 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
C0720318 (UMLS CUI [4])
C0244404 (UMLS CUI [5])
C0593802 (UMLS CUI [6])
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