Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

October 19, 2021 updated by: State University of New York - Upstate Medical University
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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Potential study subjects will be drawn from patients with a history of treatment for breast cancer with lumpectomy followed by radiation therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at least 2.5 years following lumpectomy and radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Collaborators

Carol M. Baldwin Breast Cancer Research Fund, Inc.

Investigators

  • Principal Investigator: Peter J Hahn, PhD, State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project # 1050425

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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