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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Cohort B (Prospective) | A prospective cohort of patients newly diagnosed between 2025 and 2030, ensuring ā„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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Observational |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Tao, MD | Contact | 008621-64175590 | 660103 | hkutao@hotmail.com |
| Chuanxu Liu, MD | Contact | 008621-64175590 | 660103 | liuchaunxu@shca.or.cn |
| Name | Affiliation | Role |
|---|---|---|
| Rong Tao, MD | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 201200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18626005 | Result | 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. |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Peripheral blood sampleļ¼tumor biopsy sample
| 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 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |