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Trial Title:
Early Assessment of Lymphoma Treatment Response Using Phased Variant Analysis With Next-Generation Sequencing
NCT ID:
NCT06550427
Condition:
Lymphoma, B-Cell
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Conditions: Keywords:
Lymphoma
NGS
Phased Variant
Early Response Assessment
Early Outcome
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ctDNA analyzed by phased variant
Description:
this observational cohort study is to investigate the correlation between ctDNA analyzed
by phased variant and the early outcome of the disease.
Arm group label:
aggressive B cell lymphoma
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.
Criteria for eligibility:
Study pop:
pathology proven aggressive B-cell lymphoma
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- • Pathology proven aggressive B-cell lymphoma
- Age ≥ 18 years old
Exclusion Criteria:
- none
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Tai-Chung Huang, Ph.d
Phone:
+886-972-651392
Email:
tch01@ntu.edu.tw
Contact backup:
Last name:
Yu-Hsuan Tuan, Bachelor
Phone:
+886-978-716459
Email:
miatuan.ntuh@gmail.com
Start date:
August 2, 2024
Completion date:
July 31, 2026
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06550427
