Clinical Trial: Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Brief Summary: Some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. The goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.

Detailed Summary: Three tubes of blood will be drawn from each subject. Two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. Subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. If the results are promising, they will be studied further and used as the basis for future prospective clinical trials.
Sponsor: State University of New York - Upstate Medical University

Current Primary Outcome: correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject [ Time Frame: at least 2.5 years following lumpectomy and radiation therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: State University of New York - Upstate Medical University

Dates:
Date Received: April 1, 2008
Date Started: August 2006
Date Completion: August 2012
Last Updated: July 8, 2011
Last Verified: July 2011