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

A Multicenter, Non-interventional, Two-cohort Study to Describe Real-world Treatment Patterns and Outcomes in Patients With Peripheral T-cell Lymphoma

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral T-Cell Lymphoma
• Intervention / Treatment: Other: Observational

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Chuanxu Liu, MD; Phone Number: 660103 008621-64175590; Email: liuchaunxu@shca.or.cn
• Study Contact Backup: Name: Rong Tao, MD; Phone Number: 660103 008621-64175590; Email: hkutao@hotmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201200
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Rong Tao, MD; Phone Number: 021-64175590; Email: hkutao@hotmail.com
      • Contact: Chuanxu Liu, MD; Phone Number: 021-64175590; Email: liuchaunxu@shca.or.cn
      • Principal Investigator: Chuanxu Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A (Retrospective); A retrospective cohort of cases diagnosed between 2010 and 2024, assembled from medical-record data. Target enrollment: 1,300-1,500 patients.	Other: Observational; Observational
Cohort B (Prospective); 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.	Other: Observational; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of PTCL Histological Subtypes according to WHO 2016 Classification	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).	Baseline (at the time of enrollment or diagnosis)
Overall Survival (OS)	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.	5 year after diagnosis
Progression-Free Survival (PFS)	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.	5 year after diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Specific Genetic Mutations	Evaluation of the number and percentage of participants carrying specific genetic alterations. Key biomarkers to be assessed include: Gene 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.	Up to 5 years (at Baseline and at time of Disease Progression/Relapse)
Expression levels of biomarker proteins	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.	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	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.	Up to 5 years

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: The First Affiliated Hospital of Zhengzhou University
• Investigators: Study Chair: Rong Tao, MD, Fudan University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Epidemiology; Biomarkers; T-cell lymphoma; Prospective cohort; Retrospective cohort
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: SHCA-PTCL-202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No