Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect differences in breast tissue between high- and low-risk populations and within the high-risk population between BrCa1 or 2 carriers and non-carriers. These differences may include differences in breast tissue composition and metabolism at time of enrollment into the study (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue change over time (possibly reflecting rate of tissue transformation from normal to ultimately malignant state).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Breast Study to Learn More About the Application of Optical Transillumination Measurements to Assess Breast Cancer Risk and to Potentially Detect the Presence of Breast Cancer.

NCT00188721

Breast Cancer

COMPLETED

Breast Study to Determine the Ability of Non-Invasive Optical Transillumination Spectroscopy to Predict Breast Density.

NCT00188682

Breast Cancer

COMPLETED

Light Based Analysis of Developing Breast Tissue in Adolescent Girls: a Feasibility Study

NCT00188591

Breast Cancer

COMPLETED

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

NCT00797199

Breast Cancer

COMPLETED

Breast Study Investigating a New Light Technique to Monitor Changes in Breast Tissue Density

NCT00188760

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Preliminary data show Optical Breast Spectroscopy (OBS)has the ability to detect tissue differences with various pathologies and age-related changes in breast tissue over a two year period. In the present study, we want to determine whether OBS has the ability to detect optical differences between women who harbor a mutation in the breast cancer susceptibility gene, BrCa1 or BrCa2, and their age-matched controls (non-carriers). More specifically, possible differences in the breast tissue at time of enrollment into the study (reflecting changes potentially occurring in adolescence) and in the rate of breast tissue change over time (reflecting rate of tissue transformation from normal to ultimately malignant state). The overall goal is to develop a pre-screening technique to survey or monitor the risk of breast tissue and to advise the earliest point when imaging techniques (e.g. MRI) should be initiated or when more drastic primary prevention measures are recommended.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

BrCa carriers (cases)

* Attending one of the three participating high-risk screening centres
* Confirmed BrCa1 or BrCa2 mutation status through genetic testing

High-Risk (cases)

* Attending one of the three participating high-risk screening centres
* Confirmed negative BrCa1/2 status through genetic testing

BrCa non-carriers (controls)

* Attain a GAIL model score of \<1.1 and have \<10% risk of carrying the BRCa mutation Determined by the Penn II model)
* Controls from high-risk screening centre with confirmed BrCa1/2 negative status through genetic testing
* Preference will be given to sisters or first degree cousins of BrCa carriers

Exclusion Criteria

Cases and Controls

* Prior diagnosis or Breast or Ovarian Cancer
* Bilateral biopsy or fine needle aspiration within 1 year of study start
* Bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation)
* Previous or current chemotherapy or prevention therapy (Tamoxifen)
* Less than 3 years post pregnancy at study start
* inability to provide informed consent due to language or cognitive difficulties

\*For controls only
* Family history of breast cancer where family member had an early diagnosis (before age 45 years)
* Family history or ovarian cancer

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lothar Lilge, PhD

Role: PRINCIPAL_INVESTIGATOR

Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9