Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abnormalities, Radiation-Induced

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Minimum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter J Hahn, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

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SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Project # 1050425

Identifier Type: -

Identifier Source: org_study_id