A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

The investigators will first use our previously collected serum samples and surgical/biopsied tissues from HBV-related HCC patients undergoing radiotherapy. The consistency of junctional clones by Capture NGS needs to be tested between both pre- and post-RT serums, and serial changes in copy numbers of vh-DNA by ddPCR are quantified in the representative cases. The same junction clones from pre-post-RT serums and surgical tissues will be confirmed and the copy number changes of vh-DNA be correlated with RT response and disease-control status.

The investigators plan to identify HBV integrations by Capture NGS and quantify the specific vh-DNA by ddPCR as personalized biomarkers from the same-patient serum samples. The investigators will further correlate clinical response and recurrence/metastasis with serial changes of vh-DNA copy numbers. The investigators have been prospectively collecting plasma samples from HBV-related HCC patients before/after RT, at 1, 4, 7 months, and at recurrence/metastasis. The investigators plan to confirm the viable role of pre-/post-RT changes of plasma vh-DNA copies of the same junction clone in post-RT response and prognosis. Moreover, The investigators will explore the recurrent/metastatic tumors arising from the original or a de novo one by identifying their clonality with HBV integration patterns. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support the consolidative use of personalized vh-DNA for earlier evaluating treatment response after RT, for post-RT disease monitoring, and for differentiating clonality at recurrence to design future clinical trial on combinational treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with HCC by dynamic image criteria and/or biopsy

HBsAg (+)

Child-Turcotte-Pugh (CTP) class A-B liver function

Radiotherapy to liver tumor as the main treatment

Disqualifiers

Child-Turcotte-Pugh (CTP) class C liver functiECOG performance status score >2

Has had prior radiotherapy to the proposed treatment field.

< 18 years old

Trial population

we have been prospectively collecting plasma samples from HBV-related HCC patients before/after RT, at 1, 4, 7 months, and at recurrence/metastasis.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

To retrospectively analyze the Capture-NGS analysis from HBV-related HCC patients

Capture-NGS analysis and identification of HBV-human junction between pre- and post- RT

Time frame
2031/01/01
2

To retrospectively analyze the Vh-DNA specific PCR from HBV-related HCC patients

Vh-DNA specific PCR between pre- and post- RT

Time frame
2031/01/01
3

To retrospectively analyze the serial changes of serum vh-DNA copies of same junction clone from HBV-related HCC patients

Treatment response between pre- and post- RT

Time frame
2031/01/01
4

To retrospectively analyze the serial changes of survival of same junction clone from HBV-related HCC patients

Survival between pre- and post- RT

Time frame
2031/01/01

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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