Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT06549361
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Study on Extranodal DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5023}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Time Frame: Baseline up to data cut-off (up to approximately 1 year)', 'description': 'Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Time Frame: Baseline up to data cut-off (up to approximately 1 year)', 'description': 'Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Clinical characteristics form', 'timeFrame': 'Baseline up to data cut-off (up to approximately 1 year)', 'description': 'Clinical characteristics from data filled into registry forms by physicians and data managers, including but not limited to values of lactate dehydrogenase, clinical stage, performance status, age ≥ 60 years and number and location of extranodal localizations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Extranodal'], 'conditions': ['Lymphoma', 'Extranodal Lymphoma', 'Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.', 'detailedDescription': "DLBCL is a highly common aggressive non-Hodgkin's lymphoma. For specific extranodal sites of DLBCL, traditional chemotherapy protocols often cannot provide satisfactory results for patients. The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, including the distribution of involved sites (such as central nervous system, testes, skin, breast, gastrointestinal tract, etc.), prognosis of diffuse large B-cell lymphoma with involvement of different extranodal sites, genetic mutation characteristics, correlation with molecular subtypes, impact of different treatment regimens on efficacy, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement or non-Hodgkin lymphoma of rare pathological types attending participating centres.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. ≥ 18 years (including 18 years).\n* 2\\. Pathologically diagnosed with diffuse large B-cell lymphoma according to the 2016 WHO classification, including non-specific types and various special subtypes.\n* 3\\. Newly diagnosed DLBCL with involvement of extranodal organs.\n* 4\\. Patients who have received clinical treatment for lymphoma.\n* 5.Patients with measurable lesions, including at least one effective efficacy assessment.\n\nExclusion Criteria:\n\n* 1\\. Patients receiving supportive care only.\n* 2\\. Patients who cannot obtain effective efficacy assessment data.'}, 'identificationModule': {'nctId': 'NCT06549361', 'briefTitle': 'A Retrospective Study on Extranodal DLBCL', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Retrospective Clinical Study of Extranodal Diffuse Large B-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'ENI-DLBCL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No interventions need to be specified for this study', 'type': 'OTHER', 'description': 'No interventions need to be specified for this study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'First Deputy Director, Hematology Department', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}