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

NCT04268056 | Unknown

• 1 other identifier: 0141-19-RMB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Radiation dermatitis; Radio Therapy; Microbiome Profile

Outcome Measures

Primary Outcomes (2)

• Radiation Dermatitis grade

  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.

  through study completion, an average of 1 year

• Microbiome composition

  Collection of skin culture samples from body regions surrounding the RT treatment area and a control area

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App)

  through study completion, an average of 1 year

Study Arms (1)

RT patients

100 patients with breast cancer undergoing radiation therapy

Diagnostic Test: Collection of skin culture samples

Interventions

Collection of skin culture samples 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.

RT patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer undergoing radiation therapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AceTech: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin microbiome samples

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Roxolyana Abdah-Borthnyak, MD

  Director, Radiation Service for Female Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 13, 2020
• Study Start: November 1, 2020
• Primary Completion: July 20, 2021
• Study Completion: November 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

IL (1)