Real-world Outcomes of Peripheral T-cell Lymphoma: A Multicenter Retrospective and Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational.
- Who it may be relevant to
- Registry conditions: Peripheral T-Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Non-interventional, Two-cohort Study to Describe Real-world Treatment Patterns and Outcomes in Patients With Peripheral T-cell Lymphoma
Overview
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.
Detailed description
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.
Interventions
- Other Observational
Observational
Primary outcome measures
- Distribution of PTCL Histological Subtypes according to WHO 2016 Classification [Time frame: Baseline (at the time of enrollment or diagnosis)]
- Overall Survival (OS) [Time frame: 5 year after diagnosis]
- Progression-Free Survival (PFS) [Time frame: 5 year after diagnosis]
Secondary outcome measures (3)
- Frequency of Specific Genetic Mutations [Time frame: Up to 5 years (at Baseline and at time of Disease Progression/Relapse)]
- Expression levels of biomarker proteins [Time frame: Up to 5 years (at Baseline and at time of Disease Progression/Relapse)]
- Incidence of Treatment-Emergent Adverse Events (TEAEs) assessed by CTCAE v5.0 [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Age ≥18 years, with a histopathologic diagnosis of PTCL (any subtype per WHO 2016 classification of hematolymphoid neoplasms).
- Cohort A: Patients diagnosed and treated at participating centers between 2010 and 2024.
- Cohort B: Patients newly diagnosed from October 2025 onward.
- Availability of basic diagnostic and treatment records .
Exclusion criteria
- Indeterminate diagnosis or missing pathology report.
- Patients diagnosed at an outside institution who did not receive their primary treatment and follow-up at a participating center.
- Diagnoses of NK/T-cell lymphoma or primary cutaneous T-cell lymphomas.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Publications
- 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. PMID 18626005
Identifiers
NCT: NCT07270861 · SHCA-PTCL-202501