NCT07480837

Dynamic Monitoring of Plasma ctDNA for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma

Dynamic Monitoring of Plasma Circulating Tumor DNA (ctDNA) for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma: An Observational Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

For patients with newly diagnosed or relapsed/metastatic B-cell non-Hodgkin lymphoma following first-line treatment, peripheral blood samples are collected before treatment and at various treatment time points to monitor circulating tumor DNA (ctDNA), aiming to investigate the correlation between dynamic ctDNA changes and patient prognosis.

Detailed description

This study is a prospective, observational, single-center clinical research aimed at exploring the correlation between the dynamic changes of plasma circulating tumor DNA (ctDNA) before and after treatment and the prognosis of patients with B-cell non-Hodgkin's lymphoma (B-NHL). A total of 60 patients who were initially treated with evaluable target lesions and were capable of undergoing molecular pathological testing, either in the initial treatment stage or after relapse/refractory treatment, were planned to be included. All patients will provide peripheral blood samples for ctDNA testing at the pre-treatment stage, during the mid-treatment stage, and after the end of treatment. Simultaneously, standard efficacy assessment PET-CT examinations will be conducted. The primary endpoint of the study is progression-free survival (PFS), while the secondary endpoints include overall response rate (ORR), overall survival (OS), and the consistency analysis between ctDNA clearance rate and PET-CT metabolic complete response (CMR).

Conditions

• B-Cell Non-Hodgkin Lymphoma

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-01-01
• Completion: 2031-01-01
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: China