A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma
Developing a Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma Treated With Radiotherapy: Personalized Cell-free Virus-host Chimera DNA
1 other identifier
observational
95
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2023
Longer than P75 for all trials
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
First Submitted
Initial submission to the registry
January 30, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2031
March 3, 2023
January 1, 2023
7.9 years
January 30, 2023
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
2031/01/01
To retrospectively analyze the Vh-DNA specific PCR from HBV-related HCC patients
Vh-DNA specific PCR between pre- and post- RT
2031/01/01
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
2031/01/01
To retrospectively analyze the serial changes of survival of same junction clone from HBV-related HCC patients
Survival between pre- and post- RT
2031/01/01
To prospectively test the concordance of vh-DNA copies between serum and plasma samples
Calculate the percentage of identical vhDNA sets between the simultaneously collected serum and plasma samples in the same patients
2031/01/01
To prospectively analyze the serial changes of plasma vh-DNA copies of same junction clone are associated with treatment response
Treatment response will be determined as the best response in serial image follow-ups up to 6 months after completion of RT. Responses will be classified as completion response, partial response, stable disease, and progressive disease by the definition of mRECIST.
2031/01/01
To prospectively analyze the serial changes of plasma vh-DNA copies of same junction clone are associated with overall survival
It will be calculated from the last fraction of radiotherapy until death from any cause of last follow-up.
2031/01/01
To distinguish the clonality of recurrent HCC as the original or a de novo one for post-radiotherapy patterns of failure
Detected tumor-specific vh-DNA in the plasma collected at the time of recurrence/metastasis to determine its clonality.
2031/01/01
Eligibility Criteria
we have been prospectively collecting plasma samples from HBV-related HCC patients before/after RT, at 1, 4, 7 months, and at recurrence/metastasis.
You may qualify if:
- 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
You may not qualify if:
- Child-Turcotte-Pugh (CTP) class C liver functiECOG performance status score \>2
- Has had prior radiotherapy to the proposed treatment field.
- \< 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
We 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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chia-Hsien Cheng
Employee
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2023
First Posted
March 3, 2023
Study Start
March 1, 2023
Primary Completion (Estimated)
January 31, 2031
Study Completion (Estimated)
January 31, 2031
Last Updated
March 3, 2023
Record last verified: 2023-01