Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by State University of New York - Upstate Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Carol M. Baldwin Breast Cancer Research Fund, Inc.
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00652678
First received: April 1, 2008
Last updated: July 8, 2011
Last verified: July 2011

April 1, 2008
July 8, 2011
August 2006
Not Provided
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00652678 on ClinicalTrials.gov Archive Site
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Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients
Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

peripheral blood mononuclear cells

Non-Probability Sample

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

Abnormalities, Radiation-Induced
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
August 2012
Not Provided

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
Female
48 Years and older
No
Contact: Dena Martin, CRA 315-464-5262 martind@upstate.edu
United States
 
NCT00652678
Project # 1050425
No
Peter J. Hahn, PhD - Associate Professor, Department of Radiation Oncology, SUNY Upstate Medical University
State University of New York - Upstate Medical University
Carol M. Baldwin Breast Cancer Research Fund, Inc.
Principal Investigator: Peter J Hahn, PhD State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP