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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268056
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Radiation Dermatitis Diagnostic Test: Collection of skin culture samples

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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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : April 2021

Group/Cohort Intervention/treatment
RT patients
100 patients with breast cancer undergoing radiation therapy
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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
Skin microbiome samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Patients with breast cancer undergoing radiation therapy.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Sivan Luder, VP R&D +972508490794 Sivan@acemanan-tech.com
Contact: Dana Shwartz, CA +972507509103 dana@acemanan-tech.com

Sponsors and Collaborators
AceTech
Investigators
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Principal Investigator: Rahamim Ben Yosef, MD Director of Radiation Oncology at Rambam Health Care Campus
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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: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AceTech:
Radiation dermatitis
Radio Therapy
Microbiome Profile
Additional relevant MeSH terms:
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Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries