HBV-host cfDNA as Minimal Residual Tumor Marker for HBV-related HCC
A New Biomarker for Detection of Minimal Residual Tumor in Hepatitis-B Virus Related Hepatocellular Carcinoma After Curative Therapies: The Cell-free Circulating HBV-host Chimera DNA Fragment
1 other identifier
observational
50
1 country
1
Brief Summary
Early stage HCC is treated by curative surgical resection or by local ablation (such as radio-frequency) as the current standard of care. The complete removal of clinical visible HCC is then confirmed by imaging by MRI or CT, or by a decline of tumor marker (AFP or PIVKA). However, despite an apparent complete removal of the HCC, those post-curative patients frequently develop tumor recurrence at a rate ranging 10-50% within the first year. The high rate of early HCC recurrence indicated a minimal residual HCC after the curative therapies in a significant proportion of patients. A better and more specific biomarker for detecting the residual HCC will improve the patients' prognosis prediction and therapeutic plan. To detect the minimal residual HCC, a biomarker unique to the tumor is needed. Currently, the cell-free circulating DNA carrying tumor-specific somatic mutations has been advocated as a promising one. It has been applied to investigate the tumor responses or resistances to cancer therapy. However, currently it is restricted to detect or follow only large advanced cancer, because of the difficulty in separating or enriching the cfDNA with tumor-specific mutations from the cfDNA from normal cells. In this project, the investigators proposed that one class of somatic mutation in HBV-related HCC, namely the insertion mutagenesis by integrated HBV DNA, could be adopted to circumvent this difficulty. HBV DNA integration has been found in the chromosomes of about 90% of HBV-related HCC and the integration site is unique to individual HCC. The HBV-host junction DNA fragment from one HCC is therefore a tumor-specific biomarker. Such fragments can be released into the circulation as cell-free circulating DNAs, and the detection of the HBV-host chimera DNAs in the circulation is a reliable evidence for the presence of the tumor in the patient. Therefore the cf circulating HBV-host chimera DNA is proposed to assay any minimal residual HCC after curative therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJanuary 13, 2017
January 1, 2017
2.7 years
June 22, 2016
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
vh-chimera DNA
Detection of the HBV-host chimera DNA in blood sample.----- one blood sampling at the time of HCC recurrence.
week 4 after surgery.
Secondary Outcomes (3)
Tumor size (measured in the longest dimension in cm)
after medical imaging or pathology report completion, up to 2 weeks.
tumor grade (Grades I-IV)
after medical imaging or pathology report completion, up to 2 weeks.
recurrence-free survival time ----measurement in weeks
from the date of surgery until the date of first documented HCC recurrence or date of death from any cause, whichever came first, assessed up to 24 months
Other Outcomes (3)
Routine liver function test (ALT in IU/L)
week 4 after surgery, ---- one blood sampling at the time of HCC recurrence.
Routine liver function test (AST in IU/L)
week 4 after surgery, ---- one blood sampling at the time of HCC recurrence.
current HCC marker (AFP ng/ml)
week 4 after surgery, ---- one blood sampling at the time of HCC recurrence.
Eligibility Criteria
HBV-related HCC patients that receive surgical removal of tumor.
You may qualify if:
- HBV-related HCC patients that receive surgical removal of tumor.
You may not qualify if:
- unsuitable for surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Biospecimen
Tumor (T) and non-Tumor (NT) tissue, and peripheral blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pei-Jer Chen, MD-PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2016
First Posted
January 13, 2017
Study Start
May 1, 2016
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
January 13, 2017
Record last verified: 2017-01