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NCT06550427

Early Assessment of Lymphoma Treatment Response Using Phased Variant Analysis With Next-Generation Sequencing

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

Lymphoma is a prevalent lymphoid malignancy globally and in Taiwan. Large B-cell lymphoma (LBCL) is the most common subtype of aggressive B-cell lymphoma. LBCL's aggressive nature manifests through extranodal involvement, severe symptoms, and relative refractoriness to therapies, leading to a 5-year overall survival rate of 60-70% across developed countries and poorer outcomes in high-risk patients with primary refractory disease. Chemoimmunotherapy remains the primary treatment for LBCL, requiring comprehensive assessment through clinical and imaging examinations, biomarkers, and molecular testing. Currently, computed tomography (CT) and positron emission tomography (PET) scans are the standard modalities for treatment response evaluation, though their radioactive nature calls for the development of safer alternatives. Circulating tumor DNA (ctDNA) analysis has emerged as a promising field, providing insights into tumor molecular characteristics, clinical status, and treatment response by analyzing DNA fragments released from tumor cells into the bloodstream. Dynamic monitoring of ctDNA during treatment can effectively gauge therapeutic efficacy-decreasing ctDNA concentrations suggest successful treatment, while increasing levels may indicate treatment failure or tumor recurrence. The detection of ctDNA has been much improved through advances in next-generation sequencing (NGS) technologies, particularly taking advantage of analyzing phased variants, consecutive gene mutations on the same chromosome, enhances the sensitivity and specificity.

Official title: Early Assessment of Aggressive B-Cell Lymphoma Treatment Response and Prediction of Recurrence Using Phased Variant Analysis With Next-Generation Sequencing

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-08-09

Completion Date

2027-07-31

Last Updated

2025-06-17

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

ctDNA analyzed by phased variant

this observational cohort study is to investigate the correlation between ctDNA analyzed by phased variant and the early outcome of the disease.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan