Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis
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ClinicalTrials.gov Identifier: NCT04268056 |
Recruitment Status :
Recruiting
First Posted : February 13, 2020
Last Update Posted : November 27, 2020
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Condition or disease | Intervention/treatment |
---|---|
Radiation Dermatitis | Diagnostic Test: Collection of skin culture samples |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Characterization of Skin Microbiome Profile Before and During Radiation Therapy and it's Correlation to the Occurrence and Severity of Radiation Dermatitis |
Actual Study Start Date : | November 1, 2020 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | October 2021 |
Group/Cohort | Intervention/treatment |
---|---|
RT patients
100 patients with breast cancer undergoing radiation therapy
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Diagnostic Test: Collection of skin culture samples
Collection of skin culture samples using a sterile swab. the swab will gently rubbed on the skin on the 3 different skin areas. The target areas are i) regions surrounding the RT treatment area (if possible, not from the scar area or from skin folds areas), ii) a control site of the normal (healthy) breast , iii) a control area on the forehead. |
- Radiation Dermatitis grade [ Time Frame: through study completion, an average of 1 year ]Study participant will be evaluated by physician and nurse for the occurrence and the severity of RD. Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring.
- Microbiome composition [ Time Frame: through study completion, an average of 1 year ]Collection of skin culture samples from body regions surrounding the RT treatment area and a control area
- Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App) [ Time Frame: through study completion, an average of 1 year ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
- Prior usage of other topical and systemic medications within 21 days of first swab collection
- Prior usage of topical cosmetic products, creams, lotions, or gels within 14 days of first swab collection in areas where samples are taken.
- Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
- Prior organ or bone marrow transplant
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268056
Contact: Sivan Luder, VP R&D | +972508490794 | Sivan@acemanan-tech.com | |
Contact: Dana Shwartz, CA | +972507509103 | dana@acemanan-tech.com |
Israel | |
Rambam Medical Center | Recruiting |
Haifa, Israel | |
Contact: Roxolyana Abdah-Borthnyak, MD |
Principal Investigator: | Roxolyana Abdah-Borthnyak, MD | Director, Radiation Service for Female Cancer |
Responsible Party: | AceTech |
ClinicalTrials.gov Identifier: | NCT04268056 |
Other Study ID Numbers: |
0141-19-RMB |
First Posted: | February 13, 2020 Key Record Dates |
Last Update Posted: | November 27, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Radiation dermatitis Radio Therapy Microbiome Profile |
Dermatitis Radiodermatitis Skin Diseases Radiation Injuries Wounds and Injuries |