Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis (NCT04268056) | Clinical Trial Compass
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Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis
Israel100 participantsStarted 2020-11-01
Plain-language summary
The purpose of this study is to characterize the skin microbiome profile of breast cancer patients before and after receiving Radio Therapy treatments, and evaluate the relationship between the microbiome profile and radiation dermatitis severity (grade) that the patient will develop. Such characterizations can lead to potential biomarkers and/or therapeutic targets that can be used for the prognosis, prevention and treatment of this condition.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Age ≥ 18 years
✓. Histological confirmation of breast malignancy
✓. Primary or recurrent disease eligible
✓. Patients after breast lumpectomy and that scheduled to receive radiotherapy
✓. Patients that receive minimum of 45 Gy
✓. Ability to complete questionnaire(s) by themselves or with assistance
✓. Provide informed written consent
Exclusion criteria
✕. Patients with prior radiotherapy to any portion of the planned treatment site
✕. Tumour involvement of the skin
✕. Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
✕. Patient with other skin diseases/ skin disorders
✕. Recent use of systemic or topical antibiotics or antifungal medications within 21 days of first swab collection.
✕. Recent use of any of the following within 21 days of first swab collection: o Systemic or topical steroids o Use of systemic immunosuppressant drugs o Use of ultraviolet light therapy
✕
What they're measuring
1
Radiation Dermatitis grade
Timeframe: through study completion, an average of 1 year
2
Microbiome composition
Timeframe: through study completion, an average of 1 year