Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Terminated

• Conditions: Abnormalities, Radiation-Induced

• Registration Number: NCT00652678
• Lead Sponsor: State University of New York - Upstate Medical University

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 Description

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-09
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Breast cancer treatment: lumpectomy followed by external beam XRT to breast
• Age at the time of radiotherapy treatment: 45-65 years old
• XRT dose to breast: >/= 4500 and </= 5200 cGy, fraction size 180 or 200 cGy
• Dose distribution: no area receiving >/= 112% of prescribed dose
• Follow-ups: patients must be >/= 2.5 years post-treatment

Exclusion Criteria

• Reconstructive surgery to involved breast

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject	at least 2.5 years following lumpectomy and radiation therapy

Trial Locations

Locations (1)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States