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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.

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188721
First received: September 9, 2005
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

This study aims to evaluate if a light based technique, called Transillumination Breast Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor which provides a better odds ratio than mammographic parenchymal density.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Transillumination for Breast Cancer Risk Assessment

Resource links provided by NLM:


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

Estimated Enrollment: 500
Study Start Date: July 2006
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women with confirmed unilateral breast carcinoma or ductal carcinoma in situ (DCIS)
2
Women without radiological suspicious lesions, matched to cases by age (± 2.5 years), date of screening mammogram, and screening center.

Detailed Description:

In a previous cross sectional study in a group of women without breast cancer and with varying degrees of parenchymal density patterns, a strong association was demonstrated between Transillumination Breast Spectroscopy (TIBS) and x-ray derived mammographic density. From this, we expect that TIBS should also provide a comparable odds ratio (4-6) as mammographic density for breast cancer risk shown in other independent epidemiological studies. It is possible that TIBS may provide complementary information and a higher odds ratio if compared to the incidence of breast cancer. In contrast to mammography derived parenchymal density pattern, no historical TIBS data is available for a retrospective analysis and hence a cross sectional study within a group of screened women is proposed. We hypothesize that TIBS provides physical information about the breast tissue which can be used to construct a breast cancer risk predictor with an odd ratio > 6.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Cases and controls recruited from the Breast Imaging Clinic at Princess Margaret Hospital or the Marvelle Koffler Centre at Mount Sinai Hospital (Toronto, Ontario, Canada)

Criteria

Inclusion Criteria:

  • Are in good health and capable of providing consent
  • Are willing to come in to the Princess Margaret Hospital for a single visit to meet with a female research assistant

Exclusion Criteria:

  • Have had breast augmentation or reduction
  • Have a personal history of breast cancer
  • Have had a previous bilateral fine needle aspiration or core biopsy
  • Have a breast tattoo
  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: NCT00188721

Locations
Canada, Ontario
Ontario Cancer Institute, Princess Maraget Hospital
Toronto, Ontario, Canada, M5G 2M9
Ontario Cancer Institute, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, 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

Publications:
Responsible Party: Dr. Lothar Lilge, University Health Network
ClinicalTrials.gov Identifier: NCT00188721     History of Changes
Other Study ID Numbers: UHNREB#03-0462-CE, HC#96142
Study First Received: September 9, 2005
Last Updated: August 11, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 25, 2014