Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients
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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 |
- 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 |
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 |
Potential study subjects will be drawn from patients with a history of treatment for breast cancer with lumpectomy followed by radiation therapy.
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| Contact: Dena Martin, CRA | 315-464-5262 | martind@upstate.edu |
| United States, New York | |
| SUNY Upstate Medical University | Recruiting |
| Syracuse, New York, United States, 13210 | |
| 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:
|
Congenital Abnormalities Abnormalities, Radiation-Induced Breast Neoplasms Radiation Injuries Wounds and Injuries |
Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013