ID

17236

Description

Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00280930

Link

https://clinicaltrials.gov/show/NCT00280930

Keywords

Versions (1)
  1. 9/1/16 9/1/16 -
Uploaded on

September 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Post-Menopausal NCT00280930

English

Eligibility Post-Menopausal NCT00280930

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal status defined as: women >55 years of age-no spontaneous menses for at least 12 months; in women < 55 years-no spontaneous menses within the past 12 months and with an fsh level >34.4 iu/i; bilateral oophorectomy
Description

postmenopausal status; no spontaneous menses; fsh level; bilateral oophorectomy

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0025344
UMLS CUI [3]
C0202022
UMLS CUI [4]
C0278321
if subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal
Description

prior invasive breast cancer must have been surgically removed with no evidence of metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1521996
UMLS CUI [2]
C0027627
baseline mammogram (within 6 months) indicating mammographic density occupying >25% (grade 4/5, 5/6 or 6/6) of the breast tissue
Description

mammographic density

Data type

boolean

Alias
UMLS CUI [1]
C1268717
baseline breast examination demonstrating no clinical evidence of breast cancer
Description

baseline breast examination demonstrating no clinical evidence of breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C1276755
acceptable quality dexa of the l2-l4 postero-anterior (pa) spine and hup must be performed 6 months of randomization
Description

Dexa scan

Data type

boolean

Alias
UMLS CUI [1]
C1510486
subject is willing and able to complete the quality of life questionnaire in either english or french
Description

Compliance behaviour

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mammogram suspicious for breast cancer (unless subsequently ruled out)
Description

Mammogram suspicious for breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1277190
UMLS CUI [1,2]
C0024671
patient's with prior malignancies are eligible unless they have metastatic disease
Description

Malignancies, metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0027627
uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
Description

uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0014130
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0024523
current chemotherapy or immunotherapy
Description

chemotherapy or immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
hormone replacement therapy or evista (raloxifene) discontinued less than three months before baseline mammogram
Description

Hormone replacement therapy or evista (raloxifene)

Data type

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0618111
tamoxifen therapy discontinued less than six months prior to randomization
Description

Tamoxifen

Data type

boolean

Alias
UMLS CUI [1]
C0039286
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Similar models

Eligibility Post-Menopausal NCT00280930

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
postmenopausal status; no spontaneous menses; fsh level; bilateral oophorectomy
Item
postmenopausal status defined as: women >55 years of age-no spontaneous menses for at least 12 months; in women < 55 years-no spontaneous menses within the past 12 months and with an fsh level >34.4 iu/i; bilateral oophorectomy
boolean
C0232970 (UMLS CUI [1])
C0025344 (UMLS CUI [2])
C0202022 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
prior invasive breast cancer must have been surgically removed with no evidence of metastases
Item
if subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal
boolean
C0853879 (UMLS CUI [1,1])
C1521996 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
mammographic density
Item
baseline mammogram (within 6 months) indicating mammographic density occupying >25% (grade 4/5, 5/6 or 6/6) of the breast tissue
boolean
C1268717 (UMLS CUI [1])
baseline breast examination demonstrating no clinical evidence of breast cancer
Item
baseline breast examination demonstrating no clinical evidence of breast cancer
boolean
C1276755 (UMLS CUI [1])
Dexa scan
Item
acceptable quality dexa of the l2-l4 postero-anterior (pa) spine and hup must be performed 6 months of randomization
boolean
C1510486 (UMLS CUI [1])
Compliance behaviour
Item
subject is willing and able to complete the quality of life questionnaire in either english or french
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mammogram suspicious for breast cancer
Item
mammogram suspicious for breast cancer (unless subsequently ruled out)
boolean
C1277190 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
Malignancies, metastatic disease
Item
patient's with prior malignancies are eligible unless they have metastatic disease
boolean
C0006826 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
Item
uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
boolean
C0025517 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0024523 (UMLS CUI [4])
chemotherapy or immunotherapy
Item
current chemotherapy or immunotherapy
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Hormone replacement therapy or evista (raloxifene)
Item
hormone replacement therapy or evista (raloxifene) discontinued less than three months before baseline mammogram
boolean
C0282402 (UMLS CUI [1])
C0618111 (UMLS CUI [2])
Tamoxifen
Item
tamoxifen therapy discontinued less than six months prior to randomization
boolean
C0039286 (UMLS CUI [1])
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