Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-25 @ 12:33 AM
Study NCT ID:
NCT04245150
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Breast skin and GI samples from participants with breast cancer following breast conserving surgery will be collected. These samples will then be analyzed using DNA extraction and 16S rRNA gene sequencing with an in-house bioinformatics group. Data will be used to define the microbiome profile for this subset of breast cancer patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2019-12-20', 'studyFirstSubmitQcDate': '2020-01-27', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiome profile as assessed by stool sample', 'timeFrame': 'At baseline', 'description': 'Microbiome profile as assessed by stool sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample'}, {'measure': 'Microbiome profile as assessed by breast skin sample', 'timeFrame': 'At baseline', 'description': 'Microbiome profile as assessed by breast skin sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample'}, {'measure': 'Correlation of the microbiome to incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring', 'timeFrame': '3 months post-treatment', 'description': 'The microbiome profiles identified will be correlated with incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring by visual assessment. Maximum toxicity during radiation will be recorded.\n\nGrade 0: None Grade 1: Faint erythema or dry desquamation Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['DCIS', 'Invasive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.', 'detailedDescription': 'This study will prospectively enroll 50 participants with with biopsy proven Ductal carcinoma in situ (DCIS) or invasive breast cancer 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.\n\nEach participant will have a post-surgery pre-radiotherapy stool and breast skin sample obtained, complete a medical record review for clinical data, and have complete an interview/questionnaire in order to learn about potential risk factors which will be included in the data collection form. Included information will include Stage (T, N, M, composite), receipt of chemotherapy, radiation fields and dose, BMI, hypertension (HTN), Diabetes Mellitus (DM), smoking status, history of breast infection yes/no (Data Collection Form).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with biopsy proven DCIS or invasive breast cancer, 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer patients with DCIS or invasive breast cancer\n* Undergoing breast conserving surgery and adjuvant radiation\n* Subjects must be willing and able to provide breast skin samples\n\nExclusion Criteria:\n\n* Active clinical breast infection (on antiobiotic for skin/breast infection or clinical diagnosis)\n* Refuse or are unable to sign informed consent form\n* Past history of breast cancer'}, 'identificationModule': {'nctId': 'NCT04245150', 'briefTitle': 'Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity', 'orgStudyIdInfo': {'id': 'CASE5118'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ductal Carcinoma In Situ (DCIS) or invasive breast cancer', 'description': 'Participants with DCIS or invasive breast cancer', 'interventionNames': ['Other: Stool sample', 'Other: Skin Swab Sample']}], 'interventions': [{'name': 'Stool sample', 'type': 'OTHER', 'description': 'Stool sample', 'armGroupLabels': ['Ductal Carcinoma In Situ (DCIS) or invasive breast cancer']}, {'name': 'Skin Swab Sample', 'type': 'OTHER', 'description': 'Skin Swab Sample', 'armGroupLabels': ['Ductal Carcinoma In Situ (DCIS) or invasive breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Chirag Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}