ID

20107

Beschrijving

Study of Breast Cancer Prevention by Letrozole in High Risk Women; ODM derived from: https://clinicaltrials.gov/show/NCT00579826

Link

https://clinicaltrials.gov/show/NCT00579826

Trefwoorden

  1. 06-02-17 06-02-17 -
Geüploaded op

6 februari 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00579826

Eligibility Breast Cancer NCT00579826

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
post-menopausal women at high risk for development of breast cancer
Beschrijving

Post-menopausal: high risk for breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C4047809
on a stable dose of hormone replacement therapy
Beschrijving

Hormone replacement therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0282402
have cytomophologic evidence of hyperplasia +/- atypia and ki-67 expression >1.5% in benign breast epithelial cells acquired by rpfna
Beschrijving

Rpfna: Cytology

Datatype

boolean

Alias
UMLS CUI [1,1]
C3640066
UMLS CUI [1,2]
C0010819
serum level of 25-oh vitamin d of at least 30 ng/ml prior to study entry
Beschrijving

25-oh vitamin d level

Datatype

boolean

Alias
UMLS CUI [1]
C1255280
willing to have a repeat rpfna and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug
Beschrijving

Willing to participate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C2348568
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of osteoporosis or osteoporotic fracture.
Beschrijving

Osteoporosis or osteoporotic fracture

Datatype

boolean

Alias
UMLS CUI [1]
C0521170
prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
Beschrijving

Invasive breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
current and chronic use of cox-2 specific inhibitors or nsaids
Beschrijving

Cox-2 specific inhibitors or nsaids

Datatype

boolean

Alias
UMLS CUI [1]
C1257954
UMLS CUI [2]
C0003211
receiving treatment for rheumatoid arthritis or fibromyalgia
Beschrijving

Treatment for rheumatoid arthritis or fibromyalgia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0016053
current history of poorly controlled migraines or perimenopausal symptoms
Beschrijving

Migraines or perimenopausal symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C0149931
UMLS CUI [2]
C0949062
currently receiving other investigational agents.
Beschrijving

Investigational agents

Datatype

boolean

Alias
UMLS CUI [1]
C1875319
receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.
Beschrijving

Aromatase inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C0593802

Similar models

Eligibility Breast Cancer NCT00579826

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Post-menopausal: high risk for breast cancer
Item
post-menopausal women at high risk for development of breast cancer
boolean
C0232970 (UMLS CUI [1,1])
C4047809 (UMLS CUI [1,2])
Hormone replacement therapy
Item
on a stable dose of hormone replacement therapy
boolean
C0282402 (UMLS CUI [1])
Rpfna: Cytology
Item
have cytomophologic evidence of hyperplasia +/- atypia and ki-67 expression >1.5% in benign breast epithelial cells acquired by rpfna
boolean
C3640066 (UMLS CUI [1,1])
C0010819 (UMLS CUI [1,2])
25-oh vitamin d level
Item
serum level of 25-oh vitamin d of at least 30 ng/ml prior to study entry
boolean
C1255280 (UMLS CUI [1])
Willing to participate
Item
willing to have a repeat rpfna and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug
boolean
C0600109 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Osteoporosis or osteoporotic fracture
Item
prior history of osteoporosis or osteoporotic fracture.
boolean
C0521170 (UMLS CUI [1])
Invasive breast cancer
Item
prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
boolean
C0853879 (UMLS CUI [1])
Cox-2 specific inhibitors or nsaids
Item
current and chronic use of cox-2 specific inhibitors or nsaids
boolean
C1257954 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
Treatment for rheumatoid arthritis or fibromyalgia
Item
receiving treatment for rheumatoid arthritis or fibromyalgia
boolean
C0087111 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0016053 (UMLS CUI [2,2])
Migraines or perimenopausal symptoms
Item
current history of poorly controlled migraines or perimenopausal symptoms
boolean
C0149931 (UMLS CUI [1])
C0949062 (UMLS CUI [2])
Investigational agents
Item
currently receiving other investigational agents.
boolean
C1875319 (UMLS CUI [1])
Aromatase inhibitor
Item
receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.
boolean
C0593802 (UMLS CUI [1])

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