Early Assessment of Lymphoma Treatment Response Using Phased Variant Analysis With Next-Generation Sequencing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ctDNA analyzed by phased variant.
- Who it may be relevant to
- Registry conditions: Lymphoma, Hodgkin Lymphoma, T-cell Lymphoma, Waldenstrom Macroglobulinaemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Assessment of Aggressive B-Cell Lymphoma Treatment Response and Prediction of Recurrence Using Phased Variant Analysis With Next-Generation Sequencing
Overview
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.
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.
Primary outcome measures
- 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.]
Eligibility criteria
Inclusion criteria
- • Pathology proven lymphoma
- Age ≥ 18 years old
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06550427 · 202404016RINB