Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients



Status:Completed
Conditions:Breast Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:48 - Any
Updated:4/2/2016
Start Date:August 2006
End Date:August 2012
Contact:Dena Martin, CRA
Email:martind@upstate.edu
Phone:315-464-5262

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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.

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.

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
- 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
We found this trial at
1
site
750 East Adams Street
Syracuse, New York 13210
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from
Syracuse, NY
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