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
  Purpose

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.


Condition
Abnormalities, Radiation-Induced

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

peripheral blood mononuclear cells


Estimated Enrollment: 45
Study Start Date: August 2006
Estimated Study Completion Date: August 2012
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.

  Eligibility

Ages Eligible for Study:   48 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652678

Contacts
Contact: Dena Martin, CRA 315-464-5262 martind@upstate.edu

Locations
United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Carol M. Baldwin Breast Cancer Research Fund, Inc.
Investigators
Principal Investigator: Peter J Hahn, PhD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Peter J. Hahn, PhD - Associate Professor, Department of Radiation Oncology, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00652678     History of Changes
Other Study ID Numbers: Project # 1050425
Study First Received: April 1, 2008
Last Updated: July 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Breast cancer
Radiation effects

Additional relevant MeSH terms:
Abnormalities, Radiation-Induced
Breast Neoplasms
Breast Diseases
Congenital Abnormalities
Neoplasms
Neoplasms by Site
Radiation Injuries
Skin Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 30, 2014