Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mount Sinai Hospital, Canada
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Lothar Lilge, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00500383
First received: July 10, 2007
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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).


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Difference in rate of change between the high risk groups and the respective controls [ Time Frame: over the 4 year duration of the study ] [ Designated as safety issue: No ]
    the primary optical measurements are utilized to determine principal component scores in the analysis which in turn will be used as time dependent variable in a linear regression analysis to determine the rate of change.


Estimated Enrollment: 900
Study Start Date: October 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cases are recruited from three participating high-risk screening centres: Familial Breast and Ovarian Cancer Programs at Mount Sinai Hospital and/or Princess Margaret Hospital (Toronto, Ontario, Canada), the Juravinski Cancer Center (Hamilton, Ontario, Canada) and Women's College Hsopital (toronto, Ontario, Canada). Controls are recruited from the respective geographical locations.

Criteria

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
  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: NCT00500383

Locations
Canada, Ontario
Juravinski Cancer Center, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Princess Margaret Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
University Health Network, Toronto
Mount Sinai Hospital, Canada
Hamilton Health Sciences Corporation
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, Senior Scientist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00500383     History of Changes
Other Study ID Numbers: UHNREB#07-0689-CE, HC#124313
Study First Received: July 10, 2007
Last Updated: June 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Breast Cancer Risk
BRCA1
BRCA2
Breast Cancer Susceptibility gene
Optical Transillumination Spectroscopy
Transillumination Breast Spectroscopy

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

ClinicalTrials.gov processed this record on August 28, 2014