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

Sponsor
National Taiwan University Hospital
Study ID
NCT06550427
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 13, 2024
Start date
Aug 9, 2024
Status verified
Jun 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: lymphoma
    Pathology proven lymphoma

Primary Outcome Measure

Correlation between ctDNA analyzed by phased variant and early outcome of lymphoma [ Time Frame: From the date of enrollment, up to 24 months or date of death from any cause. ]

Central Contacts

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