Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Abnormalities, Radiation-Induced Clinical Trial

Official title:

Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00652678
• Other study ID #: Project # 1050425
• Status: Terminated
• Start date: August 2006
• Est. completion date: August 2012

Study information

• Verified date: September 2013
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abnormalities, Radiation-Induced

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	Carol M. Baldwin Breast Cancer Research Fund, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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