An observational study in Hepatocellular Carcinoma, sponsored by TCM Biotech International Corp.. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by TCM Biotech International Corp. · Observational
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 virus-host chimera DNA (vh-DNA) from HBV integration sites in HCC a reliable evidence even in the patient with a tiny tumor which is not large enough to be detected by the image scan.
The goal of this observational study is to compare the prediction ability of vh-DNA with the other biomarkers for monitoring the recurrent of HBV-related HCC. The main questions that aim to answer are the sensitivity and specificity of vh-DNA/AFP/ALP-L3/PIVKA-II/TERTC2280 when the gold standard is the guideline of HCC diagnosis.
The surgical tissues and plasma samples from the participants would be collected undergoing the HCC recession surgery when joining the study at the beginning, in order to identify the HBV integration in tumor by Capture NGS and quantify the specific vh-DNA in plasma by ddPCR as personalized biomarkers for minimal residual disease (MRD) monitoring. Moreover, the consistency of vh-DNA from tumor will be validated by pre-operative plasma.
Then the participants will be asked to performed the visit at 2, 5, 8, 11, 14 months after the HCC recession surgery. The plasma sample for vh-DNA/AFP/ AFP-L3/ PIVKA-II/ TERTp C228T testing and the image data from ultrasound, CT or MRI would also be collected at these visits. When the vh-DNA testing result is positive and there is no recurrence at 14 months after the HCC recession surgery, some participants will be asked to followed at 17, 20 months.
Researcher will compare the sensitivity, specificity and predict day of vh-DNA with AFP/ AFP-L3/ PIVKA-II/ TERTp C228T as a biomarker for HCC surveillance. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support to use for monitoring post-operative recurrence.
In addition, the investigators will explore the performance of TERTp C228T mutation from non-HBV HCC patients. As a different target of ctDNA for HCC, TERTp C228T will be identified using surgical tissues from HCC patients, and plasma samples from the same patient before/after operation will be tested by ddPCR . It will be evaluated that TERTp C228T is predictive or not for recurrence monitoring of HCC.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 207 is below the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →TCM Biotech International Corp. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The patients with HCC are scheduled to undergo hepatic resection or liver transplant.
Exclusion Criteria:
Sensitivity (vh-DNA vs AFP) (the vh-DNA which could be detected in the pre-operative plasma of participants.)
Compare the sensitivity of vh-DNA with AFP as a biomarker for HCC surveillance.
Time frame: HCC recurrence within 14 months of post-operative.
Sensitivity (vh-DNA vs AFP) (the vh-DNA which could not be detected in the pre-operative plasma of participants.)
Compare the sensitivity of vh-DNA with AFP as a biomarker for HCC surveillance.
Time frame: HCC recurrence within 14 months of post-operative.
Sensitivity (vh-DNA vs AFP-L3/PIVKA-II/TERTp C228T)
Compare the sensitivity of vh-DNA with AFP-L3/ PIVKA-II/ TERTp C228T as a biomarker for HCC surveillance.
Time frame: HCC recurrence within 14 months of post-operative.
Specificity (vh-DNA vs AFP/AFP-L3/PIVKA-II/TERTp C228T)
Compare the specificity of vh-DNA with AFP/ AFP-L3/ PIVKA-II/ TERTp C228T as a biomarker for HCC surveillance.
Time frame: The 14 months of post-operative.
Predicted days (vh-DNA vs AFP/AFP-L3/PIVKA-II/TERTp C228T)
Compare the predicted day of vh-DNA with AFP/AFP-L3/PIVKA-II/TERTp C228T as a biomarker before HCC recurrence.
Time frame: HCC recurrence within 14 months of post-operative.
Clonality
To clarify the clonality of recurrent HCC is same as the original one or is a de novo one.
Time frame: HCC recurrence within 14 months of post-operative.
Sensitivity (TERT C228T vs AFP/AFP-L3/PIVKA-II)
Compare the sensitivity of TERTp C228T with AFP/ AFP-L3/ PIVKA-II as a biomarker for HCC surveillance.
Time frame: HCC recurrence within 14 months of post-operative.
Plan to share: No
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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TCM Biotech International Corp.