Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-03 @ 5:53 PM
Study NCT ID:
NCT07270861
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Outcomes of Peripheral T-cell Lymphoma: A Multicenter Retrospective and Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood sample，tumor biopsy sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of PTCL Histological Subtypes according to WHO 2016 Classification', 'timeFrame': 'Baseline (at the time of enrollment or diagnosis)', 'description': 'The number and percentage of participants diagnosed with each specific subtype of Peripheral T-Cell Lymphoma (e.g., PTCL-NOS, AITL, ALCL, ENKTL, etc.). Diagnosis is confirmed by pathological review based on the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th edition, 2017).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '5 year after diagnosis', 'description': 'OS is defined as the time from the date of pathological diagnosis to the date of death from any cause. For patients who are lost to follow-up, survival time will be censored at the date of last contact.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '5 year after diagnosis', 'description': "PFS is defined as the time from the date of pathological diagnosis to the date of the first documented disease progression (PD) or death from any cause, whichever occurs first. Disease progression is assessed based on the investigator's evaluation of radiological and clinical data."}], 'secondaryOutcomes': [{'measure': 'Frequency of Specific Genetic Mutations', 'timeFrame': 'Up to 5 years (at Baseline and at time of Disease Progression/Relapse)', 'description': 'Evaluation of the number and percentage of participants carrying specific genetic alterations. Key biomarkers to be assessed include:\n\nGene Mutations: TET2, DNMT3A, IDH2, RHOA, TP53, EZH2, and genes related to the PI3K-AKT pathway, assessed by Next-Generation Sequencing (NGS) or ct-DNA analysis. Correlations between these biomarkers and clinical outcomes (response, survival) will be analyzed.'}, {'measure': 'Expression levels of biomarker proteins', 'timeFrame': 'Up to 5 years (at Baseline and at time of Disease Progression/Relapse)', 'description': 'Protein/Pathological Markers: Expression of PD-1/PD-L1, CD30, Ki-67 proliferation index, and EBV status, assessed by Immunohistochemistry (IHC) or In Situ Hybridization (ISH). Correlations between these biomarkers and clinical outcomes (response, survival) will be analyzed.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (TEAEs) assessed by CTCAE v5.0', 'timeFrame': 'Up to 5 years', 'description': 'Safety will be assessed by recording the number of participants with adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. This includes treatment-related deaths and incidence of second primary malignancies.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T-cell lymphoma', 'Retrospective cohort', 'Prospective cohort', 'Epidemiology', 'Biomarkers'], 'conditions': ['Peripheral T-Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '18626005', 'type': 'RESULT', 'citation': 'Vose J, Armitage J, Weisenburger D; International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008 Sep 1;26(25):4124-30. doi: 10.1200/JCO.2008.16.4558. Epub 2008 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to characterize the epidemiology, clinicopathologic features, and survival outcomes of Chinese patients with PTCL; to develop and validate prognostic models to this population; to compare the real-world effectiveness and safety of alternative therapeutic strategies; to elucidate molecular mechanisms underlying treatment resistance and relapse; to identify actionable targets and predictive biomarkers.', 'detailedDescription': 'Due to disease heterogeneity and variability in clinical practice, establishing a large-scale Chinese PTCL database to characterize real-world treatment patterns and clinical outcomes is a critical undertaking. A retrospective cohort will define the clinical epidemiology of the disease, while a prospective cohort will delineate current treatment pathways and outcomes in routine practice and explore the molecular features of PTCL in the Chinese population, thereby providing evidence to support precision therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a multicenter, non-interventional, two-cohort study comprising a retrospective cohort (A) and a prospective cohort (B). We will include patients with a histopathologic diagnosis of peripheral T-cell lymphoma that meets the 2016 WHO criteria, excluding NK/T-cell lymphoma and primary cutaneous T-cell lymphomas. Eligible cases must have complete medical records and follow-up data.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years, with a histopathologic diagnosis of PTCL (any subtype per WHO 2016 classification of hematolymphoid neoplasms).\n* Cohort A: Patients diagnosed and treated at participating centers between 2010 and 2024.\n* Cohort B: Patients newly diagnosed from October 2025 onward.\n* Availability of basic diagnostic and treatment records .\n\nExclusion Criteria:\n\n* Indeterminate diagnosis or missing pathology report.\n* Patients diagnosed at an outside institution who did not receive their primary treatment and follow-up at a participating center.\n* Diagnoses of NK/T-cell lymphoma or primary cutaneous T-cell lymphomas.'}, 'identificationModule': {'nctId': 'NCT07270861', 'briefTitle': 'Real-world Outcomes of Peripheral T-cell Lymphoma: A Multicenter Retrospective and Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Multicenter, Non-interventional, Two-cohort Study to Describe Real-world Treatment Patterns and Outcomes in Patients With Peripheral T-cell Lymphoma', 'orgStudyIdInfo': {'id': 'SHCA-PTCL-202501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A (Retrospective)', 'description': 'A retrospective cohort of cases diagnosed between 2010 and 2024, assembled from medical-record data.\n\nTarget enrollment: 1,300-1,500 patients.', 'interventionNames': ['Other: Observational']}, {'label': 'Cohort B (Prospective)', 'description': 'A prospective cohort of patients newly diagnosed between 2025 and 2030, ensuring ≥5-year follow-up for all survivors.\n\nTarget sample size: 1,000-1,500 cases, estimated from participating centers\' annual diagnostic volumes over a 5-year accrual period. The cohort should be multidimensionally representative, including: (i) geographic coverage across North, East, South, Southwest, and Northeast China; (ii) hospital tiers with tertiary ("Class III Grade A") institutions as the core and selective inclusion of prefecture-level hospitals; and (iii) economic diversity spanning regions with differing levels of socioeconomic development.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'Observational', 'armGroupLabels': ['Cohort A (Retrospective)', 'Cohort B (Prospective)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201200', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong Tao, MD', 'role': 'CONTACT', 'email': 'hkutao@hotmail.com', 'phone': '021-64175590'}, {'name': 'Chuanxu Liu, MD', 'role': 'CONTACT', 'email': 'liuchaunxu@shca.or.cn', 'phone': '021-64175590'}, {'name': 'Chuanxu Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Rong Tao, MD', 'role': 'CONTACT', 'email': 'hkutao@hotmail.com', 'phone': '008621-64175590', 'phoneExt': '660103'}, {'name': 'Chuanxu Liu, MD', 'role': 'CONTACT', 'email': 'liuchaunxu@shca.or.cn', 'phone': '008621-64175590', 'phoneExt': '660103'}], 'overallOfficials': [{'name': 'Rong Tao, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Chief', 'investigatorFullName': 'Rong Tao', 'investigatorAffiliation': 'Fudan University'}}}}