Peripheral T-Cell Lymphoma
Conditions
Keywords
T-cell lymphoma, Retrospective cohort, Prospective cohort, Epidemiology, Biomarkers
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.
Interventions
OTHERObservational
Observational
Sponsors
Fudan University
The First Affiliated Hospital of Zhengzhou University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of PTCL Histological Subtypes according to WHO 2016 Classification | 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). |
| Overall Survival (OS) | 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. |
| Progression-Free Survival (PFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Specific Genetic Mutations | Up to 5 years (at Baseline and at time of Disease Progression/Relapse) | 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 | Up to 5 years (at Baseline and at time of Disease Progression/Relapse) | 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 | Up to 5 years | 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. |
Countries
China
Contacts
CONTACTRong Tao, MD
CONTACTChuanxu Liu, MD
STUDY_CHAIRRong Tao, MD
Fudan University
Outcome results
None listed