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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
Sponsor:
Information provided by (Responsible Party):
AceTech

Tracking Information
First Submitted Date February 6, 2020
First Posted Date February 13, 2020
Last Update Posted Date November 27, 2020
Actual Study Start Date November 1, 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2020)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 11, 2020)
Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App) [ Time Frame: through study completion, an average of 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis
Official Title Characterization of Skin Microbiome Profile Before and During Radiation Therapy and it's Correlation to the Occurrence and Severity of Radiation Dermatitis
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Skin microbiome samples
Sampling Method Non-Probability Sample
Study Population Patients with breast cancer undergoing radiation therapy.
Condition Radiation Dermatitis
Intervention 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.
Study Groups/Cohorts RT patients
100 patients with breast cancer undergoing radiation therapy
Intervention: Diagnostic Test: Collection of skin culture samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 11, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sivan Luder, VP R&D +972508490794 Sivan@acemanan-tech.com
Contact: Dana Shwartz, CA +972507509103 dana@acemanan-tech.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT04268056
Other Study ID Numbers 0141-19-RMB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party AceTech
Study Sponsor AceTech
Collaborators Not Provided
Investigators
Principal Investigator: Roxolyana Abdah-Borthnyak, MD Director, Radiation Service for Female Cancer
PRS Account AceTech
Verification Date November 2020