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

NCT ID: NCT04268056

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-11-30

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.

Conditions

Radiation Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

RT patients

100 patients with breast cancer undergoing radiation therapy

Collection of skin culture samples

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AceTech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roxolyana Abdah-Borthnyak, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Radiation Service for Female Cancer

Locations

Rambam Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

0141-19-RMB

Identifier Type: -

Identifier Source: org_study_id