Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis

• Conditions: Radiation Dermatitis
• Interventions: Diagnostic Test: Collection of skin culture samples

• Registration Number: NCT04268056
• Lead Sponsor: AceTech

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Study Start: 2020-11-01
• Status Verified: 2021-07
• Primary Completion: 2021-07-20
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Age ≥ 18 years
2. Histological confirmation of breast malignancy
3. Primary or recurrent disease eligible
4. Patients after breast lumpectomy and that scheduled to receive radiotherapy
5. Patients that receive minimum of 45 Gy
6. Ability to complete questionnaire(s) by themselves or with assistance
7. Provide informed written consent

Exclusion Criteria

1. Patients with prior radiotherapy to any portion of the planned treatment site
2. Tumour involvement of the skin
3. Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
4. Patient with other skin diseases/ skin disorders
5. Recent use of systemic or topical antibiotics or antifungal medications within 21 days of first swab collection.
6. 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
7. Prior usage of other topical and systemic medications within 21 days of first swab collection
8. Prior usage of topical cosmetic products, creams, lotions, or gels within 14 days of first swab collection in areas where samples are taken.
9. Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
10. Prior organ or bone marrow transplant
11. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RT patients	Collection of skin culture samples	100 patients with breast cancer undergoing radiation therapy

Primary Outcome Measures

Name	Time	Method
Radiation Dermatitis grade	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	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

Secondary Outcome Measures

Name	Time	Method
Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App)	through study completion, an average of 1 year

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel