Real-world Outcomes of Peripheral T-cell Lymphoma: A Multicenter Retrospective and Prospective Cohort Study

Fudan University

Status: Enrolling

Conditions: Peripheral T-Cell Lymphoma

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT07270861

SHCA-PTCL-202501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 2 patient groups

Cohort A (Retrospective)

Description:

A retrospective cohort of cases diagnosed between 2010 and 2024, assembled from medical-record data. Target enrollment: 1,300-1,500 patients.

Treatment:

Other: Observational

Cohort B (Prospective)

Description:

A prospective cohort of patients newly diagnosed between 2025 and 2030, ensuring ≥5-year follow-up for all survivors. Target 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.

Treatment:

Other: Observational