Compare the Accuracy of ctDNA-MRD and MVI Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorZhujiang Hospital
About this trial
The aim of this study was to compare the accuracy of ctDNA-MRD longitudinal surveillance model and internationally accepted pathological MVI results in predicting recurrence after radical hepatectomy. At the same time, to explore the relationship among the two methods of predicting recurrence of hepatocellular carcinoma, postoperative adjuvant therapy and postoperative recurrence, this study further confirmed the effectiveness of ctDNA-MRD longitudinal monitoring model in monitoring postoperative recurrence of hepatocellular carcinoma and guiding treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial population
Patient with hepatocellular carcinoma who can undergo radical surgical resection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
circulating tumor cell DNA detection
Diagnostic testcirculating tumor DNA blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma
Treatment groups
152 Participants
are divided into 1 treatment groupGroup A: Patient with hepatocellular carcinoma1 intervention
Trial outcomes
Primary outcomes
1
The ROC curve of two methods are obtained according to the results of recurrence prediction 2 years after hepatectomy，and the primary outcome measure is the area under the ROC curve (AUC value) for two methods
The receiver operating characteristic curve (ROC) is made according to the recurrence of the patients after operation, and the accuracy of ctDNA-MRD longitudinal monitoring model and pathological MVI results are judged by comparing the area under the ROC curve (AUC value)
Time frame
2 yearsSecondary outcomes
1
2-year recurrence-free survival rate
percentage of recurrence-free survival 2 years after surgery
Time frame
2 yearsOther outcomes
1
1-year recurrence-free survival rate
percentage of recurrence-free survival 1 years after surgery
Time frame
1 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: