Monitoring of Breast Tissue Change Due to Hormone Replacement Therapy in Post-Menopausal Women Using Optical Breast Spectroscopy (OBS) - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto St. Michael's Hospital, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00797199

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Hormone Replacement Therapy Menopause

U.S. FDA Resources

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)

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

Biospecimen Description:

Whole blood

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2010

Groups/Cohorts
1 Women receiving treatment of Premarin.
2 Women receiving treatment of Premarin + Provera combination.
3 Women receiving treatment of Premarin + Prometrium combination.
4 Women not on HRT.

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

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
Toronto, Ontario, Canada, M5G 2M9
St. Michael's Hospital
Toronto, Ontario, Canada

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

Transillumination Breast Spectroscopy Research Program This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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 May 30; [Epub ahead of print]

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.

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
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

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Menopause
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009