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Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients


N/A
48 Years
N/A
Open (Enrolling)
Female
Abnormalities, Radiation-Induced

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Trial Information

Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients


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.


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
- 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject

Outcome Time Frame:

at least 2.5 years following lumpectomy and radiation therapy

Safety Issue:

Yes

Principal Investigator

Peter J Hahn, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

State University of New York - Upstate Medical University

Authority:

United States: Institutional Review Board

Study ID:

Project # 1050425

NCT ID:

NCT00652678

Start Date:

August 2006

Completion Date:

August 2012

Related Keywords:

  • Abnormalities, Radiation-Induced
  • Breast cancer
  • Radiation effects
  • Congenital Abnormalities
  • Abnormalities, Radiation-Induced
  • Breast Neoplasms

Name

Location
SUNY Upstate Medical University Syracuse, New York  13210