Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA
1 other identifier
observational
255
1 country
7
Brief Summary
This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
7 active sites
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
November 20, 2023
CompletedFirst Submitted
Initial submission to the registry
November 23, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
March 20, 2026
March 1, 2026
3 years
November 23, 2023
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
2-year recurrence-free survival rate
percentage of recurrence-free survival 2 years after surgery
2 years
Secondary Outcomes (1)
Correlation between ctDNA-MRD status dynamic changes and relapse
2 years
Study Arms (1)
Patient with hepatocellular carcinoma
Patient with hepatocellular carcinoma who can undergo radical resection
Interventions
blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma
Eligibility Criteria
Patient with hepatocellular carcinoma who can undergo radical surgical resection
You may qualify if:
- Male or female patients aged 18-75 years;
- Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 / stage A/stage B, eligible for radical surgery;
- ECOG physical status score is 0-1;
- Child-Pugh score is 5-6 points (Level A);
- Not received any anti-tumor therapy;
- Laboratory tests were at normal levels within 7 days before enrollment.
You may not qualify if:
- Patient can't provide blood samples for ctDNA testing;
- Patient with two or more types of tumors at the same time;
- Non-primary liver lesions;
- Pregnant or lactating women;
- Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;
- Patient with serious heart disease;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
The Sixth Affiliated Hospital of South China University of Technology
Foshan, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510220, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Shunde Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Study Officials
- PRINCIPAL INVESTIGATOR
Mingxin Pan
Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2023
First Posted
December 5, 2023
Study Start
November 20, 2023
Primary Completion (Estimated)
November 20, 2026
Study Completion (Estimated)
November 30, 2028
Last Updated
March 20, 2026
Record last verified: 2026-03