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

NCT07270861 | Recruiting DMC

• 1 other identifier: SHCA-PTCL-202501
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T-Cell Lymphoma

Keywords

T-cell lymphoma; Retrospective cohort; Prospective cohort; Epidemiology; Biomarkers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Frequency of Specific Genetic Mutations

  Up to 5 years (at Baseline and at time of Disease Progression/Relapse)

• Expression levels of biomarker proteins

  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

Study Arms (2)

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

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

Interventions

Observational OTHER

Observational

Cohort A (Retrospective); Cohort B (Prospective)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: collaborator
• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201200, China

RECRUITING

Related Publications (1)

• 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sample，tumor biopsy sample

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Rong Tao, MD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Rong Tao, MD

CONTACT

008621-64175590; hkutao@hotmail.com

Chuanxu Liu, MD

CONTACT

008621-64175590; liuchaunxu@shca.or.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chief

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: December 8, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CN (1)