Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01407770|
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : June 8, 2018
RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Radiation therapy may cause skin reactions when patients are exposed to high-energy x rays. Studying the genetic pattern of patients before and after radiation therapy may help doctors prevent toxicity and plan the best treatment.
PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin reactions in racial/ethnic groups of patients with breast cancer.
|Condition or disease||Intervention/treatment|
|Breast Cancer Cognitive Ability, General Fatigue Pain Psychosocial Deprivation Radiation Toxicity Skin Abnormalities||Genetic: DNA analysis Genetic: gene expression analysis Other: enzyme-linked immunosorbent assay Other: flow cytometry Other: laboratory biomarker analysis Other: questionnaire administration Procedure: adjuvant therapy Procedure: assessment of therapy complications Procedure: quality-of-life assessment Radiation: 3-dimensional conformal radiation therapy Radiation: breast irradiation Radiation: external beam radiation therapy Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy Radiation: whole breast irradiation|
- To develop and validate prediction biomarkers for radiation therapy (RT)-induced acute and chronic skin reactions and quality of life in five racial/ethnic groups of breast cancer patients, Whites*, Black/African Americans, Hispanic/Latinos, Asians/Native Hawaiians/Pacific Islanders, and American Indians/Alaskan Natives. NOTE: *This stratum is closed as of April 25, 2012.
- To develop polygenic models of RT-induced skin reactions with a comprehensive evaluation of genome-wide nonsynonymous single nucleotide polymorphisms (nsSNPs).
- To evaluate the levels of DNA damage (Comet assay) and radiosensitivity (Cell Cycle G2 Delay assay) in lymphocytes before and after RT.
- To test the effect of gene-gene and gene-smoking interactions on RT-induced skin reactions.
- To assess race-ethnic differences in RT-induced skin reactions, DNA damage, and radiosensitivity and to determine if the gene effects are consistent across race-ethnicity (gene-race/ethnic interactions).
OUTLINE: This is a multicenter study. Patients are stratified according to race/ethnicity (Whites* vs Black/African Americans vs Hispanic/Latinos vs Asians/Native Hawaiians/Pacific Islanders vs American Indians/Alaskan Natives). NOTE: *This stratum is closed as of April 25, 2012.
Patients undergo adjuvant radiotherapy after breast-conserving surgery.
Blood and urine samples are collected at baseline and last day of radiotherapy for genotyping, DNA damage, cell cycle assays, urine cotinine, inflammatory immune response biomarkers, and tumor-killing activity by BeadArray System, Comet assay, flow cytometry-based assay, Cell-Cycle G2 Delay Assay, Oxygen Radical Absorbance Capacity (ORAC) assay, and ELISA.
Patients are assessed for acute toxicity by research staff using the ONS Criteria for Radiation-Induced Acute Skin Toxicity at baseline, week 3, and at 1 and 2 months after radiotherapy. Patients are also assessed for chronic toxicity by research staff using the Chronic skin toxicity questionnaire (RTOG SOMA Criteria for RT- Induced Breast/Chest Wall Late Skin Toxicity) at 6 and 12 months after completion of radiotherapy. Photographs of the breast, chest wall, and contralateral breast are also taken at baseline, week 3, last day of radiotherapy, and at 1, 2, 6, and 12 months after completion of radiotherapy.
Patients complete the Breast Cancer Risk Study Questionnaire, the Functional Assessment of Cancer Therapy Breast (FACT-B), the Modified Skindex, and the B39 Quality-of-Life (QOL) Questionnaire at baseline, last day of radiotherapy, and at 1, 2, 6, and 12 months after radiotherapy.
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
- Genetic: DNA analysis
- Genetic: gene expression analysis
- Other: enzyme-linked immunosorbent assay
- Other: flow cytometry
- Other: laboratory biomarker analysis
- Other: questionnaire administration
- Procedure: adjuvant therapy
- Procedure: assessment of therapy complications
- Procedure: quality-of-life assessment
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: breast irradiation
- Radiation: external beam radiation therapy
- Radiation: hypofractionated radiation therapy
- Radiation: intensity-modulated radiation therapy
- Radiation: whole breast irradiation
- Occurrence of RT-induced early adverse skin reaction (EASR) [ Time Frame: 2 months ]The primary endpoint is RT-related skin reactions which for consistency and clarity across the study we will use the term "Early Adverse Skin Reaction" (EASR). Skin reactions will be assessed at 4 time points from the start of radiotherapy through 2 months of the post radiotherapy follow-up period. The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. The primary outcome variable will be the occurrence (or not) of RT-induced EASR defined as a grade 4 or higher toxicity (based on the ONS criteria) during the 2 months of the follow-up period of the study.
- Quality of life [ Time Frame: 12 months ]Quality of life will be assessed using the FACT-B, a modification of the Skindex-16, and a modified version of the NSABP B39 Quality of Life metric.
Biospecimen Retention: Samples With DNA
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): NCT01407770
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||James J. Urbanic, MD||Wake Forest University Health Sciences|