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

NCT00797199 | Completed

• 1 other identifier: TiBS-HRT
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer Risk; Hormone Replacement Therapy; Optical Transillumination Spectroscopy; Optical Breast Spectroscopy; Transillumination Breast Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Changes in OBS parameters

  18 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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
• Not on HRT treatment
• Current or Past HRT treatment
• Prior breast cancer
• Benign breast disease
• Bilateral breast biopsy
• Fine needle aspiration (FNA) within a year

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Unity Health Toronto: collaborator

Study Sites (2)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Related Publications (4)

• Blyschak K, Simick M, Jong R, Lilge L. Classification of breast tissue density by optical transillumination spectroscopy: optical and physiological effects governing predictive value. Med Phys. 2004 Jun;31(6):1398-414. doi: 10.1118/1.1738191.

  PMID: 15259643 BACKGROUND

• Simick MK, Jong R, Wilson B, Lilge L. Non-ionizing near-infrared radiation transillumination spectroscopy for breast tissue density and assessment of breast cancer risk. J Biomed Opt. 2004 Jul-Aug;9(4):794-803. doi: 10.1117/1.1758269.

  PMID: 15250768 BACKGROUND

• Blackmore KM, Knight JA, Jong R, Lilge L. Assessing breast tissue density by transillumination breast spectroscopy (TIBS): an intermediate indicator of cancer risk. Br J Radiol. 2007 Jul;80(955):545-56. doi: 10.1259/bjr/26858614. Epub 2007 May 30.

  PMID: 17537757 BACKGROUND

• Simick MK, Lilge L. Optical transillumination spectroscopy to quantify parenchymal tissue density: an indicator for breast cancer risk. Br J Radiol. 2005 Nov;78(935):1009-17. doi: 10.1259/bjr/14696165.

  PMID: 16249602 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: November 25, 2008
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

CA (2)