Breast CancerNCT01407770

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

An observational study of Breast Cancer and Cognitive Ability, General, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Cognitive Ability, General, Fatigue
What is being tested?: DNA analysis, gene expression analysis and enzyme-linked immunosorbent assay
Type of treatment: Surgery or procedure
How many people: 1,000 participants
Where: 1 siteUnited States
Study dates: 20 Sep 2011to 26 Aug 2014
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity

PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin reactions in racial/ethnic groups of patients with breast cancer.

Read the detailed description

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.

Conditions: Breast Cancer, Cognitive Ability, General, Fatigue, Pain, Psychosocial Deprivation, Radiation Toxicity
Being tested: DNA analysis, gene expression analysis, enzyme-linked immunosorbent assay, flow cytometry, laboratory biomarker analysis
Keywords: radiation toxicity, skin reactions secondary to radiation therapy, pain, fatigue, psychosocial effects of cancer and its treatment, depression, cognitive/functional effects, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, ductal breast carcinoma in situ
Medical subject headings: Breast Neoplasms, Fatigue, Pain, Radiation Injuries, Skin Abnormalities, Depression, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DNA analysisGenetic
Genetic
gene expression analysisGenetic
Genetic
enzyme-linked immunosorbent assayOther
Genetic
flow cytometryOther
Genetic
laboratory biomarker analysisOther
Genetic
questionnaire administrationOther
Genetic
adjuvant therapyProcedure or surgery
Genetic
assessment of therapy complicationsProcedure or surgery
Genetic
quality-of-life assessmentProcedure or surgery
Genetic
3-dimensional conformal radiation therapyRadiation
Genetic
breast irradiationRadiation
Genetic
external beam radiation therapyRadiation
Genetic
hypofractionated radiation therapyRadiation
Genetic
intensity-modulated radiation therapyRadiation
Genetic
whole breast irradiationRadiation
Genetic

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of RT-induced early adverse skin reaction (EASR)
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.
Measured: 2 months

Secondary outcomes (1)

Quality of life as measured by FACT-B
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 201126 Aug 2014

First posted2 Aug 2011 (estimated)
Study start20 Sep 2011
Primary completion26 Aug 2014
Study completion26 Aug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 1,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01407770
Sponsor's protocol ID: IRB00011809
Other IDs: U10CA081851, REBACCCWFU97609
Status last verified: Mar 2023
First submitted: 30 Jul 2011
Last updated: 28 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hu JJ, Urbanic JJ, Case LD, Takita C, Wright JL, Brown DR, Langefeld CD, Lively MO, Mitchell SE, Thakrar A, Bryant D, Baglan K, Strasser J, Baez-Diaz L, Lesser GJ, Shaw EG. Association Between Inflammatory Biomarker C-Reactive Protein and Radiotherapy-Induced Early Adverse Skin Reactions in a Multiracial/Ethnic Breast Cancer Population. J Clin Oncol. 2018 Aug 20;36(24):2473-2482. doi: 10.1200/JCO.2017.77.1790. Epub 2018 Jul 10.
PubMed 29989859

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity
ClinicalTrials.gov ID: NCT01407770
Acronym / sponsor ID: IRB00011809
Conditions: Breast Cancer, Cognitive Ability, General, Fatigue, Pain, Psychosocial Deprivation, Radiation Toxicity
Keywords: radiation toxicity, skin reactions secondary to radiation therapy, pain, fatigue, psychosocial effects of cancer and its treatment, depression, cognitive/functional effects, stage IA breast cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 1,000 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 20 Sep 2011 (actual)
Primary completion: 26 Aug 2014 (actual)
Study completion: 26 Aug 2014 (actual)
First posted: 2 Aug 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin reactions in racial/ethnic groups of patients with breast cancer.

Detailed description

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).

Patients undergo adjuvant radiotherapy after breast-conserving surgery.

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Race/ethnicity to include Whites*, Black/African Americans (AA), Hispanic/Latinos, Asians/Native Hawaiians/Pacific Islanders, and Native American or Alaskan

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DNA analysisGenetic	Genetic	–
gene expression analysisGenetic	Genetic	–
enzyme-linked immunosorbent assayGenetic	Other	–
flow cytometryGenetic	Other	–
laboratory biomarker analysisGenetic	Other	–
questionnaire administrationGenetic	Other	–
adjuvant therapyGenetic	Procedure or surgery	–
assessment of therapy complicationsGenetic	Procedure or surgery	–
quality-of-life assessmentGenetic	Procedure or surgery	–
3-dimensional conformal radiation therapyGenetic	Radiation	–
breast irradiationGenetic	Radiation	–
external beam radiation therapyGenetic	Radiation	–
hypofractionated radiation therapyGenetic	Radiation	–
intensity-modulated radiation therapyGenetic	Radiation	–
whole breast irradiationGenetic	Radiation	–

Primary outcome

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.

1 secondary outcome

Quality of life as measured by FACT-B
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Background: PubMed 29989859Hu JJ, Urbanic JJ, Case LD, Takita C, Wright JL, Brown DR, Langefeld CD, Lively MO, Mitchell SE, Thakrar A, Bryant D, Baglan K, Strasser J, Baez-Diaz L, Lesser GJ, Shaw EG. Association Between Inflammatory Biomarker C-Reactive Protein and Radiotherapy-Induced Early Adverse Skin Reactions in a Multiracial/Ethnic Breast Cancer Population. J Clin Oncol. 2018 Aug 20;36(24):2473-2482. doi: 10.1200/JCO.2017.77.1790. Epub 2018 Jul 10.

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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James J. Urbanic, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Cognitive Ability, General, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of RT-induced early adverse skin reaction (EASR) (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01407770, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.