Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT04268056
Status:
UNKNOWN
Last Update Posted:
2021-07-21
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011855', 'term': 'Radiodermatitis'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Skin microbiome samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-11', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Dermatitis grade', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Microbiome composition', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Collection of skin culture samples from body regions surrounding the RT treatment area and a control area'}], 'secondaryOutcomes': [{'measure': 'Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App)', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation dermatitis', 'Radio Therapy', 'Microbiome Profile'], 'conditions': ['Radiation Dermatitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer undergoing radiation therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histological confirmation of breast malignancy\n3. Primary or recurrent disease eligible\n4. Patients after breast lumpectomy and that scheduled to receive radiotherapy\n5. Patients that receive minimum of 45 Gy\n6. Ability to complete questionnaire(s) by themselves or with assistance\n7. Provide informed written consent\n\nExclusion Criteria:\n\n1. Patients with prior radiotherapy to any portion of the planned treatment site\n2. Tumour involvement of the skin\n3. Patients with active rash, pre-existing dermatitis, lupus, or scleroderma\n4. Patient with other skin diseases/ skin disorders\n5. Recent use of systemic or topical antibiotics or antifungal medications within 21 days of first swab collection.\n6. 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\n7. Prior usage of other topical and systemic medications within 21 days of first swab collection\n8. Prior usage of topical cosmetic products, creams, lotions, or gels within 14 days of first swab collection in areas where samples are taken.\n9. Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome\n10. Prior organ or bone marrow transplant\n11. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety'}, 'identificationModule': {'nctId': 'NCT04268056', 'briefTitle': "Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis", 'organization': {'class': 'INDUSTRY', 'fullName': 'AceTech'}, 'officialTitle': "Characterization of Skin Microbiome Profile Before and During Radiation Therapy and it's Correlation to the Occurrence and Severity of Radiation Dermatitis", 'orgStudyIdInfo': {'id': '0141-19-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RT patients', 'description': '100 patients with breast cancer undergoing radiation therapy', 'interventionNames': ['Diagnostic Test: Collection of skin culture samples']}], 'interventions': [{'name': 'Collection of skin culture samples', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['RT patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Roxolyana Abdah-Borthnyak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Radiation Service for Female Cancer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AceTech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}