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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Pathology proven lymphoma

Age ≥ 18 years old

Disqualifiers

none

Trial population

pathology proven lymphoma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: lymphoma1 intervention

Trial outcomes

Primary outcomes

1

Correlation between ctDNA analyzed by phased variant and early outcome of lymphoma

The primary endpoint of this observational cohort study is to investigate the correlation between ctDNA analyzed by phased variant and the early outcome of aggressive B cell lymphoma

Time frame
From the date of enrollment, up to 24 months or date of death from any cause.

Secondary outcomes

Other outcomes

Sponsors and contacts

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