NCT06449846

Compare the Accuracy of ctDNA-MRD and MVI Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma

Compare the Accuracy of Circulating Tumor DNA Longitudinal Monitoring Minimal Residual Disease and Microvascular Invasion Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 152 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma Resectable
• Surgery
• Recurrence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

4 sites across 1 country: China