An observational study in Hepatocellular Carcinoma Resectable, Surgery and Recurrence, sponsored by Zhujiang Hospital. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by Zhujiang Hospital · Observational
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.
The recurrence rate of hepatocellular carcinoma (HCC) after radical hepatectomy is high, and there is no universally accepted adjuvant therapy to prevent recurrence of liver cancer at present.The high-risk recurrent population can not be accurately and dynamically located. The results showed that minimal residual disease (MRD) was the root of recurrence of HCC, and the results of MRD were the important indicator of adjuvant therapy. Our previous research confirmed that the circulating tumor DNA (ctDNA)-MRD monitoring model can accurately predict the recurrence of HCC, which provides important evidence for the application of MRD in predicting the recurrence of early HCC. It was also found in the retrospective analysis that the patients with ctDNA positive after radical hepatectomy were treated with targeted therapy and other comprehensive therapies, while ctDNA converting to negative, the tumor-free survival was significantly prolonged.
Microvascular invasion (MVI) is a pathological concept, which refers to the nests of cancer cells in the lumen of small blood vessels under the microscope, the results of MVI can be obtained by pathological examination of the tumor tissue after hepatectomy. MVI is common in HCC and is associated with early recurrence and decreased survival. MVI is an important determinant of survival after radical hepatectomy, the grade (severity) of MVI is generally associated with tumor stage and the rate of liver cancer disease progression, which has been widely studied and recognized internationally.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 152 is close to the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.
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Patient with hepatocellular carcinoma who can undergo radical surgical resection
Exclusion Criteria:
Patient with hepatocellular carcinoma who can undergo radical resection
Diagnostic Test: circulating tumor cell DNA detection
circulating tumor DNA blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma
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 years
2-year recurrence-free survival rate
percentage of recurrence-free survival 2 years after surgery
Time frame: 2 years
1-year recurrence-free survival rate
percentage of recurrence-free survival 1 years after surgery
Time frame: 1 years
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Zhujiang Hospital