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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01208779 |
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Date of registration:
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23/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
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Scientific title:
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An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01208779 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Dr Jasna Pesic |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D.spec of oncology, Institute for oncology Vojvodina, Sremska Kamenica |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Postmenopausal females with estrogen receptor positive breast cancer that are
currently treated with aromatase inhibitor (AI) medication
- Provision of subject informed consent
Exclusion Criteria:
- If participating in any clinical trial, the subject cannot take part in this study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hormon Receptor Positive Breast Cancer
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Primary Outcome(s)
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Evaluate compliance rate, as assessed by investigator, after 12 months from baseline.
[Time Frame: 12 months]
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Secondary Outcome(s)
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Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months
[Time Frame: 12 months]
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Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months
[Time Frame: 12 months]
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Primary disease (breast cancer) characteristics: receptor status, disease stage
[Time Frame: 12 months]
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Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status
[Time Frame: 12 months]
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Evaluate compliance rate, assessed by investigator, after 6 months of follow up
[Time Frame: 12 months]
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Disease management data: treatment/treatment changes
[Time Frame: 12 months]
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Secondary ID(s)
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NIS-ORS-DUM-2010/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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