Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 10:57 AM
Study NCT ID:
NCT06966050
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center MRD Registry for Inflammatory Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-24', 'size': 194553, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-25T15:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)\n\nScore scale: (1-30 questions to assess the impact of participants quality of life)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To collect data from participants with IBC who may have had MRD testing and may have surgery in the future.', 'detailedDescription': 'Primary Objectives\n\n-To determine the incidence of protocol specified pre-surgery MRD-positivity in IBC (assessment between completion of planned systemic therapy and surgery).\n\nSecondary Objectives\n\n* To establish the feasibility of multi-institutional MRD data collection using standard of care Signatera analysis in IBC participants.\n* To evaluate the association of pre-surgery MRD to pathologic response.\n* To evaluate participant reported QOL for worry about recurrence based in participants receiving MRD results\n* To establish protocol-optional baseline and longitudinal MRD data collection in IBC participants and report the frequency of MRD longitudinally\n* To determine the median lead time between the first MRD-positive result and clinical recurrence.\n* To determine whether adjuvant therapies decrease the amount of MRD in participants, and the association with relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson Cancer Center', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or males ≥18 years of age with the ability to understand and sign a written\n* Participants who have a clinical diagnosis of stage III or IV inflammatory breast cancer (IBC).\n* Participants who are planning to have or already completed a minimum of one blood draw for Signatera testing, for which the result and clinical data can be deposited into the study database.\n* Participants must be within eight months of diagnosis and have not undergone breast surgery for this diagnosis of breast cancer.\n* Participants must be English-speaking.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06966050', 'briefTitle': 'Multi-center MRD Registry for Inflammatory Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Multi-center MRD Registry for Inflammatory Breast Cancer', 'orgStudyIdInfo': {'id': '2025-0415'}, 'secondaryIdInfos': [{'id': 'NCI-2025-03109', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Participants will fill out a quality-of-life questionnaire and complete a MRD test.', 'interventionNames': ['Behavioral: Quality-of-life Questionnaire']}], 'interventions': [{'name': 'Quality-of-life Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to fill out a quality-of-life questionnaire, which will take about 10-15 minutes to complete.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sadia Saleem, MD', 'role': 'CONTACT', 'email': 'ssaleem@mdanderson.org', 'phone': '281-566-1900'}, {'name': 'Angela Alexander', 'role': 'CONTACT', 'email': 'aalexand@mdanderson.org', 'phone': '713-792-9137'}, {'name': 'Sadia Saleem, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Sadia Saleem, MD', 'role': 'CONTACT', 'email': 'ssaleem@mdanderson.org', 'phone': '281-566-1900'}, {'name': 'Angela Alexander', 'role': 'CONTACT', 'email': 'aalexand@mdanderson.org', 'phone': '713-792-9137'}], 'overallOfficials': [{'name': 'Sadia Saleem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}