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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
Sponsor study identifier
observational
50
1 country
1
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
June 22, 2016
Actual (reported)January 13, 2017
Actual (reported)January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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
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.
HBV-related HCC patients that receive surgical removal of tumor.
National Taiwan University Hospital
Taipei, 100, Taiwan
Tumor (T) and non-Tumor (NT) tissue, and peripheral blood.
Pei-Jer Chen, MD-PhD
National Taiwan University Hospital
First Submitted
June 22, 2016
First Posted
January 13, 2017
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2019
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 13, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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