Clinical and Biological Cohort Study of EBV-Positive T/NK-Cell Lymphoproliferative Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRong Tao

About this trial

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 criteria

Qualifiers

Age 18 years or older.

Newly diagnosed Epstein-Barr virus-positive T/NK-cell lymphoproliferative disease meeting World Health Organization diagnostic criteria.

For the retrospective cohort: diagnosis of extranodal NK/T-cell lymphoma between January 1, 2017 and December 31, 2025 at a participating center.

Extranodal NK/T-cell lymphoma;

Disqualifiers

For the retrospective cohort: no usable survival follow-up information, inability to confirm survival status, or inability to calculate the principal survival outcomes.

For the prospective cohort: unwillingness or inability to participate in protocol-defined longitudinal clinical follow-up.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,500 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Rong Tao

Lead sponsor

Fudan University

Sponsor institution