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.
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 .
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.
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.
Cohort
Prospective
Observational
Other interventionObservational
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).
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.
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.
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.
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.
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.
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Fudan University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
