Viewing Study NCT00188721



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Last Modification Date: 2024-10-26 @ 9:17 AM
Study NCT ID: NCT00188721
Status: COMPLETED
Last Update Posted: 2011-08-12
First Post: 2005-09-09

Brief Title: 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
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: Transillumination for Breast Cancer Risk Assessment
Status: COMPLETED
Status Verified Date: 2011-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
HC96142 None None None