Monitoring of Breast Tissue Change Due to Hormone Replacement Therapy in Post-menopausal Women Using OBS (TiBS-HRT)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Short-term Evaluations of Breast Tissue Change in Post-menopausal Women Using Optical Breast Spectroscopy (OBS)|
- Changes in OBS parameters [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
1-Treatment Group 1
Women receiving HRT treatment of Premarin.
2-Treatment Group 2
Women receiving combination HRT treatment of Premarin + Provera.
3- Treatment Group 3
Women receiving combination HRT treatment of Premarin + Prometrium.
Women not on HRT or healthy controls.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00797199
|Contact: Samantha Dick, BScH, DipHSc||416-946-4501 ext firstname.lastname@example.org|
|Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Jennifer Xanthopoulos, BSch, 416-946-4501 ext 5891 email@example.com|
|Principal Investigator: Lothar Lilge, PhD|
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Amy Strauss 416-864-6060 ext 8183 Straussa@smh.ca|
|Sub-Investigator: Christine Derzko, MD|
|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|