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Clinical Trials/NCT00188721
NCT00188721CompletedNot Applicable

Transillumination for Breast Cancer Risk Assessment

University Health Network, Toronto2 sites in 1 country500 target enrollmentStarted: July 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
500
Locations
2

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
30 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Investigators

Sponsor Class
Other

Study Sites (2)

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