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Active Not Recruiting
NCT07920757
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Sex: All
Healthy volunteers: No
Enrollment: 50
Sponsor: Fujian Medical University Union Hospital
Location: Fujian Medical University Union Hospital Fuzhou Fujian
Summary
This retrospective observational study characterises the tumour immune microenvironment and clonal architecture of relapsed or refractory extranodal NK/T-cell lymphoma (ENKTCL). Archival tumour tissue and blood samples collected during routine care are profiled by single-cell RNA sequencing, T-cell and B-cell receptor repertoire sequencing, whole-exome sequencing, and spatial transcriptomics. The study examines how immune and stromal cell states, clonal composition and spatial organisation relate to response to programmed cell death protein 1 (PD-1) blockade and to subsequent relapse.
Eligibility Criteria
Inclusion Criteria:
* Histologically confirmed extranodal NK/T-cell lymphoma, nasal type
* Relapsed or refractory disease after at least one prior line of therapy, or archival tissue available from a relapse episode
* Archival formalin-fixed paraffin-embedded tumour tissue and/or peripheral blood available for molecular profiling
* Received PD-1 or PD-L1 blockade as part of routine care at any point in the disease course
* Written informed consent for the use of residual clinical specimens in research, or a waiver of additional consent granted by the institutional ethics committee
Exclusion Criteria:
* Insufficient tissue or nucleic acid quality for the planned profiling assays
* Incomplete clinical records precluding assessment of response or outcome
Source: ClinicalTrials.gov (NCT07920757). StuddyBuddy aggregates publicly available trial information.