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Sponsors and Collaborators: |
University Health Network, Toronto St. Michael's Hospital, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00797199 |
Hormone Replacement Therapy (HRT) is a double edged sword: it can alleviate the effects of menopause for a significant proportion of the female population, however for a smaller proportion, it will induce a significant increase in their short-term and lifetime risk to develop breast cancer (BC).
Fewer women are prescribed HRT compared to a decade ago due to concerns pertaining to BC by both physicians and patients. By developing a technology that could identify women at risk for the adverse effects of HRT, during the first few months of its use, physicians may offer HRT to a wider proportion of the female population during menopause. More importantly, as it relates to BC prevention, such a technology will identify women at risk and provide a useful decision making tool regarding their care during the menopausal years.
Condition |
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Breast Cancer |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Short-Term Evaluations of Breast Tissue Change in Post-Menopausal Women Using Optical Breast Spectroscopy (OBS) |
Whole blood
Estimated Enrollment: | 80 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | May 2010 |
Groups/Cohorts |
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Women receiving treatment of Premarin.
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Women receiving treatment of Premarin + Provera combination.
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Women receiving treatment of Premarin + Prometrium combination.
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Women not on HRT.
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Ages Eligible for Study: | 30 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Post-menopausal women attending the Endocrinology Clinic at St. Michael's Hospital (Toronto, Ontario, Canada) who have elected to undergo a 1-year HRT regiment but had no prior HRT treatment. The comparison group (control) will comprise of post-menopausal women not on HRT and had no prior HRT treatment. Controls will be recruited among women at the University Health Network or attending the Endocrinology Clinic at St. Michael's Hospital (Toronto, Ontario, Canada).
Cases
Inclusion Criteria:
Exclusion Criteria:
Controls
Inclusion Criteria:
Exclusion Criteria:
Contact: Samantha Dick, BScH, DipHSc | 416-946-4501 ext 4202 | tibs@uhnresearch.ca |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
St. Michael's Hospital | |
Toronto, Ontario, Canada |
Principal Investigator: | Lothar Lilge, PhD | Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9 |
Responsible Party: | University Health Network ( Dr. Lothar Lilge ) |
Study ID Numbers: | TiBS-HRT |
Study First Received: | June 2, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00797199 History of Changes |
Health Authority: | Canada: Health Canada |
Breast Cancer Risk Hormone Replacement Therapy Optical Transillumination Spectroscopy Optical Breast Spectroscopy Transillumination Breast Spectroscopy |
Skin Diseases Breast Neoplasms Hormones Menopause Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |