Determining Molecular Drivers of Radiation Dermatitis

NCT04764682 | Completed

• 1 other identifier: 19-005445
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in skin

  A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.

  Baseline, final week of radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women aged 18 years and older

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Skin tissue. A 3mm punch biopsy will be collected at the time of surgery and during the final week of radiation treatment. One half of the sample will be placed in a separate cryovial container RNA later and the other half will be placed in a cryovial and flash frozen

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Vallow, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: February 21, 2021
• Primary Completion: March 16, 2026
• Study Completion: March 16, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)