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

NCT06550427 | Recruiting

• 1 other identifier: 202404016RINB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma; Hodgkin Lymphoma; T-cell Lymphoma; Waldenstrom Macroglobulinaemia

Keywords

Lymphoma; NGS; Phased Variant; Early Response Assessment; Early Outcome

Outcome Measures

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

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

Study Arms (1)

lymphoma

Pathology proven lymphoma

Diagnostic Test: ctDNA analyzed by phased variant

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.

lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pathology proven lymphoma

You may qualify if:

• Pathology proven lymphoma
• Age ≥ 18 years old

You may not qualify if:

• none

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

paraffin-embedded tissue sections, bone marrow blood samples and peripheral blood samples

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Lymphoma, T-Cell; Waldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Tai-Chung Huang, Ph.D

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tai-Chung Huang, Ph.D

CONTACT

+886-972-651392; tch01@ntu.edu.tw

Huang

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 13, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

TW (1)