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

NCT ID: NCT06550427

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-09

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma Hodgkin Lymphoma T-cell Lymphoma Waldenstrom Macroglobulinaemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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lymphoma

Pathology proven lymphoma

ctDNA analyzed by phased variant

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* • Pathology proven lymphoma

* Age ≥ 18 years old

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Clinical Trial Center

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tai-Chung Huang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tai-Chung Huang, Ph.D

Role: CONTACT

+886-972-651392

Huang

Role: CONTACT

Facility Contacts

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Tai-Chung Huang, Ph.d

Role: primary

+886-972-651392

Yu-Hsuan Tuan, Bachelor

Role: backup

+886-978-716459

Other Identifiers

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202404016RINB

Identifier Type: -

Identifier Source: org_study_id

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