Clinical and Biological Cohort Study of EBV-Positive T/NK-Cell Lymphoproliferative Diseases
Condition(s) studied
Study summary
This is a multicenter, non-interventional, ambidirectional cohort study of Epstein-Barr virus-positive T/NK-cell lymphoproliferative diseases. The study consists of a retrospective clinical cohort of 500 consecutively diagnosed patients with extranodal NK/T-cell lymphoma and a prospective clinical-biological cohort of 1,000 newly diagnosed patients with extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, or Epstein-Barr virus-positive nodal T/NK-cell lymphoma.
The study will characterize clinical features, treatment pathways, response, relapse or progression patterns, and long-term survival. The prospective cohort will additionally undergo standardized collection of peripheral blood and optional tumor tissue specimens at predefined clinical time points. Clinical, molecular, viral, and immune biomarkers will be evaluated for their associations with treatment response, treatment failure, disease progression, and survival. No treatment is assigned by the study.
Eligibility
Primary outcome measure(s)
- Overall Survival — From initial diagnosis to death or last confirmed follow-up, assessed for up to 10 years.
Overall survival is defined as the time from the date of initial diagnosis to death from any cause. Participants who are alive will be censored at the date on which their survival status was last confirmed. - Progression-Free Survival — From initial diagnosis to progression, relapse, death, or last disease assessment, assessed for up to 10 years.
Progression-free survival is defined as the time from the date of initial diagnosis to the first documented disease progression, disease relapse, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last assessment confirming absence of progression.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07727083 on ClinicalTrials.gov ↗ ← All trials in China