Determining Molecular Drivers of Radiation Dermatitis

March 25, 2026 updated by: Laura A. Vallow, Mayo Clinic
This study is being conducted to address key gaps in current knowledge and set the stage for rational design of strategies to prevent (pre-exposure to radiation), mitigate (post-exposure to radiation before overt signs/symptoms appear), and/or treat (post-onset of signs/symptoms) radiation dermatitis (itchy, dry skin or a rash on swollen, reddened skin).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult women aged 18 years and older

Description

Inclusion Criteria:

  • Patients receiving standard-of-care postoperative radiation therapy (2-2.7 Gy per fraction) to the breast and/or chest wall for breast cancer treatment.
  • Tissue diagnosis of breast cancer.
  • Age > 18 years
  • Signed informed consent.
  • Complete blood count within normal limits within the preceding 2 weeks.

Exclusion criteria:

  • Induction chemotherapy or biologic therapy
  • Concurrent chemotherapy or biologic therapy
  • Autoimmune disease with skin manifestations - psoriasis, dermatomyositis, scleroderma, eczema, polymyositis
  • Allergy to lidocaine anesthesia
  • Known bleeding diathesis (anticoagulation with warfarin, coagulation/bleeding disorders, vitamin C or K deficiency, thrombocytopenia)
  • History of keloids or easy scarring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in skin
Time Frame: Baseline, final week of radiation
A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.
Baseline, final week of radiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Laura Vallow, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2021

Primary Completion (Actual)

March 16, 2026

Study Completion (Actual)

March 16, 2026

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-005445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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