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Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00652678
Recruitment Status : Unknown
Verified July 2011 by State University of New York - Upstate Medical University.
Recruitment status was:  Recruiting
First Posted : April 4, 2008
Last Update Posted : July 12, 2011
Sponsor:
Collaborator:
Carol M. Baldwin Breast Cancer Research Fund, Inc.
Information provided by:
State University of New York - Upstate Medical University

Study Description
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Brief Summary:
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 or disease
Abnormalities, Radiation-Induced

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 Design
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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients
Study Start Date : August 2006
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
peripheral blood mononuclear cells

Eligibility Criteria
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Ages Eligible for Study:   48 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652678


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

Locations
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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
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Principal Investigator: Peter J Hahn, PhD State University of New York - Upstate Medical University
More Information
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Responsible Party: Peter J. Hahn, PhD - Associate Professor, Department of Radiation Oncology, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00652678    
Other Study ID Numbers: Project # 1050425
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011
Keywords provided by State University of New York - Upstate Medical University:
Breast cancer
Radiation effects
Additional relevant MeSH terms:
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Abnormalities, Radiation-Induced
Congenital Abnormalities
Radiation Injuries
Wounds and Injuries