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Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT01407770
First received: July 30, 2011
Last updated: December 16, 2013
Last verified: December 2013

July 30, 2011
December 16, 2013
September 2011
June 2013   (final data collection date for primary outcome measure)
Occurrence of RT-induced early adverse skin reaction (EASR) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
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.
  • Occurrence of RT-induced early adverse skin reaction (EASR) defined as a grade 4 or higher toxicity (based on the ONS criteria) during the 2 months follow-up [ Designated as safety issue: Yes ]
  • nsSNPs from multiple candidate pathways have dominant, recessive, additive, and/or multiplicative effects on RT-induced EASR [ Designated as safety issue: No ]
  • Individual's cellular responses to ionizing radiation contribute to RT-induced EASRs in normal tissue [ Designated as safety issue: No ]
  • Effect of gene-gene and gene-smoking interactions on RT-induced skin reactions [ Designated as safety issue: No ]
  • Race-ethnic differences in RT-induced skin reactions, DNA damage, and radiosensitivity [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01407770 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Quality of life [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity

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.

OBJECTIVES:

  • 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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood and urine samples

Probability Sample

Race/ethnicity to include Whites*, Black/African Americans (AA), Hispanic/Latinos, Asians/Native Hawaiians/Pacific Islanders, and Native American or Alaskan

  • Breast Cancer
  • Cognitive Ability, General
  • Fatigue
  • Pain
  • Psychosocial Deprivation
  • Radiation Toxicity
  • Skin Abnormalities
  • Genetic: DNA analysis
    Genetic
  • Genetic: gene expression analysis
    Genetic
  • Other: enzyme-linked immunosorbent assay
    Genetic
  • Other: flow cytometry
    Genetic
  • Other: laboratory biomarker analysis
    Genetic
  • Other: questionnaire administration
    Genetic
  • Procedure: adjuvant therapy
    Genetic
  • Procedure: assessment of therapy complications
    Genetic
  • Procedure: quality-of-life assessment
    Genetic
  • Radiation: 3-dimensional conformal radiation therapy
    Genetic
  • Radiation: breast irradiation
    Genetic
  • Radiation: external beam radiation therapy
    Genetic
  • Radiation: hypofractionated radiation therapy
    Genetic
  • Radiation: intensity-modulated radiation therapy
    Genetic
  • Radiation: whole breast irradiation
    Genetic
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
June 2013
June 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Female patients newly diagnosed with breast carcinoma including ductal carcinoma in situ (DCIS)

    • Stage 0-IIIA disease
  • Status post-lumpectomy, -quadrantectomy, or -mastectomy
  • Plan to receive adjuvant radiation to the whole breast or chest wall and/or regional lymph nodes
  • No sites that cannot send blood/urine specimens to Wake Forest by overnight (next day) express shipping

PATIENT CHARACTERISTICS:

  • *This stratum is closed as of April 25, 2012.
  • No patients who do not understand English and are unable to complete form with assistance

PRIOR CONCURRENT THERAPY:

  • Total dose > 40 Gy, dose per fraction > 1.8 - 2.0 Gy, use of 2D, 3D-conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
  • Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
  • Adjuvant hormonal therapy will be allowed prior to, during, and/or after radiotherapy (RT) at the discretion of a medical oncologist
  • Targeted therapies, such as Herceptin, will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist
  • No prior radiation to the involved breast or chest wall
  • No concurrent chemotherapy
  • No patients who underwent breast reconstruction following mastectomy

    • Placement of tissue expanders and implants are not allowed
  • No patients who have undergone MammoSite® or any other form of brachytherapy as well as those who will be treated with skin-sparing IMRT
  • Patients may not be concurrently enrolled in a protocol that involves treatment of the skin, i.e., applying lotions/moisturizers

    • Protocols that do not involve treatment of the skin are allowed
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01407770
CCCWFU97609, U10CA081851
Yes
Wake Forest Cancer Center CCOP Research Base
Wake Forest Cancer Center CCOP Research Base
National Cancer Institute (NCI)
Principal Investigator: James J. Urbanic, MD Comprehensive Cancer Center of Wake Forest University
Wake Forest Cancer Center CCOP Research Base
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP