Monitoring of Breast Tissue Change Due to Hormone Replacement Therapy in Post-menopausal Women Using OBS (TiBS-HRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Lothar Lilge, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00797199
First received: June 2, 2008
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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
Breast Cancer

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Changes in OBS parameters [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 80
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)
Groups/Cohorts
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.
4- Controls
Women not on HRT or healthy controls.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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).

Criteria

Cases

Inclusion Criteria:

  • Post-menopausal
  • Attending the Endocrinology clinic at SMH
  • Will start HRT treatment

Exclusion Criteria:

  • Current or Past HRT treatment
  • Prior breast cancer
  • Benign breast disease
  • Bilateral breast biopsy
  • Fine needle aspiration (FNA) within a year
  • Cosmetic alteration (reduction/augmentation)
  • Gynecological surgery
  • Past or current chemo- therapeutic or prevention treatment

Controls

Inclusion Criteria:

  • Not on HRT treatment

Exclusion Criteria:

  • Current or Past HRT treatment
  • Prior breast cancer
  • Benign breast disease
  • Bilateral breast biopsy
  • Fine needle aspiration (FNA) within a year
  • Cosmetic alteration (reduction/augmentation)
  • Gynecological surgery
  • Past or current chemo- therapeutic or prevention treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797199

Contacts
Contact: Samantha Dick, BScH, DipHSc 416-946-4501 ext 4202 tibs@uhnresearch.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Jennifer Xanthopoulos, BSch,    416-946-4501 ext 5891    tibs@uhnresearch.ca   
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         
Sponsors and Collaborators
University Health Network, Toronto
St. Michael's Hospital, Toronto
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Lothar Lilge, Dr. Lothar Lilge, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00797199     History of Changes
Other Study ID Numbers: TiBS-HRT
Study First Received: June 2, 2008
Last Updated: June 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Breast Cancer Risk
Hormone Replacement Therapy
Optical Transillumination Spectroscopy
Optical Breast Spectroscopy
Transillumination Breast Spectroscopy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014