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NCT04764682 Clinical Trial

Determining Molecular Drivers of Radiation Dermatitis

Breast Cancer Clinical Trial

Official title:
Determining Molecular Drivers of Radiation Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04764682
Other study ID # 19-005445
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 21, 2021
Est. completion date February 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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