A Multicenter, Non-interventional, Two-cohort Study to Describe Real-world Treatment Patterns and Outcomes in Patients With Peripheral T-cell Lymphoma
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Distribution of PTCL Histological Subtypes according to WHO 2016 Classification
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
Distribution of PTCL Histological Subtypes according to WHO 2016 Classification
Time Frame: Baseline (at the time of enrollment or diagnosis)
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).
Progression-Free Survival (PFS)
Time Frame: 5 year after diagnosis
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.
Overall Survival (OS)
Time Frame: 5 year after diagnosis
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.
Secondary Outcomes
- Expression levels of biomarker proteins(Up to 5 years (at Baseline and at time of Disease Progression/Relapse))
- Frequency of Specific Genetic Mutations(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(Up to 5 years)
Investigators
Rong Tao
Professor & Chief
Fudan University