Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00652678

Enrollment

Registered

2008-04-04

Start date

2006-08-31

Completion date

2012-08-31

Last updated

2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormalities, Radiation-Induced

Keywords

Breast cancer, Radiation effects

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

48 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject	at least 2.5 years following lumpectomy and radiation therapy

Countries

United States

Outcome results