ID

38323

Description

The Ultrasound Study of Tamoxifen; ODM derived from: https://clinicaltrials.gov/show/NCT01582074

Lien

https://clinicaltrials.gov/show/NCT01582074

Mots-clés

Versions (1)
  1. 10/10/2019 10/10/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

10 octobre 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01582074

Anglais

Eligibility Breast Neoplasms NCT01582074

1 Formulaires  
Criteria
Description

Criteria

aged 30 to 70 at the baseline visit;
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
weight is less than or equal to 350 lbs;
Description

Body Weight

Type de données

boolean

Alias
UMLS CUI [1]
C0005910
not currently pregnant or breastfeeding;
Description

Pregnancy Absent | Breast Feeding Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
no breast implants currently;
Description

Breast implants Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0179412
UMLS CUI [1,2]
C0332197
no active skin infections or wounds overlying the breast;
Description

Absence Skin infection Breast | Absence Skin wound Breast

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0037278
UMLS CUI [1,3]
C0006141
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0564444
UMLS CUI [2,3]
C0006141
the breast, as visually assessed, can fit through the ultrasound tomography ring (i.e., 20 cm in diameter);
Description

Breast Diameter | Appropriateness Ultrasound Tomography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0814634
UMLS CUI [2,2]
C3897255
no serious medical or psychiatric illnesses that would prevent voluntary informed consent.
Description

Exclusion Criteria | Illness Serious Preventing Informed Consent | Mental disorder Serious Preventing Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C0021430
cases:
Description

Clinical Study Case

Type de données

boolean

Alias
UMLS CUI [1]
C1706256
is planning to take tamoxifen for clinical indications including:
Description

Tamoxifen Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0039286
UMLS CUI [1,2]
C1301732
1. a referral from a health care professional based on a woman s personal risk of breast cancer (i.e., brca1/2 mutation carrier or 5-year predicted risk of breast cancer of greater than or equal to 1.66% according to the gail model [30]; or
Description

Patient referral Risk Breast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation Carrier | Risk Breast Carcinoma Gail Model

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034927
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0678222
UMLS CUI [2]
C3899965
UMLS CUI [3]
C3899964
UMLS CUI [4,1]
C0035647
UMLS CUI [4,2]
C0678222
UMLS CUI [4,3]
C1511297
2. a diagnosis with invasive, estrogen receptor positive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or atypical lobular or ductal hyperplasia affecting one breast; and
Description

Invasive carcinoma of breast Estrogen receptor positive | DCIS | Lobular carcinoma in situ of breast | Atypical lobular hyperplasia Affecting Breast | Atypical ductal hyperplasia Affecting Breast

Type de données

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0279754
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0279563
UMLS CUI [4,1]
C0442835
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0006141
UMLS CUI [5,1]
C0442834
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0006141
3. has never been diagnosed with breast cancer in the breast contralateral to the current diagnosis;
Description

Breast Carcinoma Absent Breast Contralateral

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0441988
is not receiving or currently planning to take chemotherapy.
Description

Chemotherapy Absent | Absence Chemotherapy Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C1301732
screen-negative comparison group:
Description

Comparison Group | Screen Negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707455
UMLS CUI [1,2]
C0441833
UMLS CUI [2,1]
C0220908
UMLS CUI [2,2]
C1513916
the most recent mammogram resulted in recommendations for continued routine screening (i.e., birads diagnostic score of 1 or "2");
Description

Mammography | Recommendation Screening Continuous | BI-RADS

Type de données

boolean

Alias
UMLS CUI [1]
C0024671
UMLS CUI [2,1]
C0034866
UMLS CUI [2,2]
C1710032
UMLS CUI [2,3]
C0549178
UMLS CUI [3]
C1511314
not currently taking oral contraceptives or menopausal hormone therapy;
Description

Oral Contraceptives Absent | Menopausal hormone therapy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009905
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0282402
UMLS CUI [2,2]
C0332197
not been previously diagnosed with breast cancer or received medications or radiation for any type of cancer;
Description

Breast Carcinoma Previous Absent | Antineoplastic Agents Absent | Absence Therapeutic radiology procedure Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0006826
not taking medicines (such as tamoxifen or raloxifene) to lower her breast cancer risk.
Description

Exclusion Criteria | Pharmaceutical Preparations Lowering Breast Carcinoma Risk | Tamoxifen | Raloxifene

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2003888
UMLS CUI [2,3]
C0678222
UMLS CUI [2,4]
C0035647
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0244404
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Similar models

Eligibility Breast Neoplasms NCT01582074

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Age
Item
aged 30 to 70 at the baseline visit;
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
weight is less than or equal to 350 lbs;
boolean
C0005910 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not currently pregnant or breastfeeding;
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Breast implants Absent
Item
no breast implants currently;
boolean
C0179412 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Skin infection Breast | Absence Skin wound Breast
Item
no active skin infections or wounds overlying the breast;
boolean
C0332197 (UMLS CUI [1,1])
C0037278 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0564444 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
Breast Diameter | Appropriateness Ultrasound Tomography
Item
the breast, as visually assessed, can fit through the ultrasound tomography ring (i.e., 20 cm in diameter);
boolean
C0006141 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0814634 (UMLS CUI [2,1])
C3897255 (UMLS CUI [2,2])
Exclusion Criteria | Illness Serious Preventing Informed Consent | Mental disorder Serious Preventing Informed Consent
Item
no serious medical or psychiatric illnesses that would prevent voluntary informed consent.
boolean
C0680251 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C0021430 (UMLS CUI [3,4])
Clinical Study Case
Item
cases:
boolean
C1706256 (UMLS CUI [1])
Tamoxifen Planned
Item
is planning to take tamoxifen for clinical indications including:
boolean
C0039286 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Patient referral Risk Breast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation Carrier | Risk Breast Carcinoma Gail Model
Item
1. a referral from a health care professional based on a woman s personal risk of breast cancer (i.e., brca1/2 mutation carrier or 5-year predicted risk of breast cancer of greater than or equal to 1.66% according to the gail model [30]; or
boolean
C0034927 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C3899965 (UMLS CUI [2])
C3899964 (UMLS CUI [3])
C0035647 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C1511297 (UMLS CUI [4,3])
Invasive carcinoma of breast Estrogen receptor positive | DCIS | Lobular carcinoma in situ of breast | Atypical lobular hyperplasia Affecting Breast | Atypical ductal hyperplasia Affecting Breast
Item
2. a diagnosis with invasive, estrogen receptor positive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or atypical lobular or ductal hyperplasia affecting one breast; and
boolean
C0853879 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
C0279563 (UMLS CUI [3])
C0442835 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0006141 (UMLS CUI [4,3])
C0442834 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0006141 (UMLS CUI [5,3])
Breast Carcinoma Absent Breast Contralateral
Item
3. has never been diagnosed with breast cancer in the breast contralateral to the current diagnosis;
boolean
C0678222 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0441988 (UMLS CUI [1,4])
Chemotherapy Absent | Absence Chemotherapy Planned
Item
is not receiving or currently planning to take chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Comparison Group | Screen Negative
Item
screen-negative comparison group:
boolean
C1707455 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0220908 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Mammography | Recommendation Screening Continuous | BI-RADS
Item
the most recent mammogram resulted in recommendations for continued routine screening (i.e., birads diagnostic score of 1 or "2");
boolean
C0024671 (UMLS CUI [1])
C0034866 (UMLS CUI [2,1])
C1710032 (UMLS CUI [2,2])
C0549178 (UMLS CUI [2,3])
C1511314 (UMLS CUI [3])
Oral Contraceptives Absent | Menopausal hormone therapy Absent
Item
not currently taking oral contraceptives or menopausal hormone therapy;
boolean
C0009905 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0282402 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Breast Carcinoma Previous Absent | Antineoplastic Agents Absent | Absence Therapeutic radiology procedure Malignant Neoplasms
Item
not been previously diagnosed with breast cancer or received medications or radiation for any type of cancer;
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0003392 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
Exclusion Criteria | Pharmaceutical Preparations Lowering Breast Carcinoma Risk | Tamoxifen | Raloxifene
Item
not taking medicines (such as tamoxifen or raloxifene) to lower her breast cancer risk.
boolean
C0680251 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C2003888 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C0035647 (UMLS CUI [2,4])
C0039286 (UMLS CUI [3])
C0244404 (UMLS CUI [4])
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