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

NCT06449846 | Not Yet Recruiting DMC

• 1 other identifier: 2024-KY-094-02
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatocellular Carcinoma Resectable; Surgery; Recurrence

Keywords

Hepatocellular Carcinoma; Circulating Tumor DNA; Minimal Residual Disease; Microvascular Invasion

Outcome Measures

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)

  2 years

Secondary Outcomes (1)

• 2-year recurrence-free survival rate

  2 years

Other Outcomes (1)

• 1-year recurrence-free survival rate

  1 years

Study Arms (1)

Patient with hepatocellular carcinoma

Patient with hepatocellular carcinoma who can undergo radical resection

Diagnostic Test: circulating tumor cell DNA detection

Interventions

circulating tumor cell DNA detection DIAGNOSTIC_TEST

circulating tumor DNA blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma

Patient with hepatocellular carcinoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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;

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (4)

Shunde Hospital of Southern Medical University

Foshan, Guangdong, China

Location

The Sixth Affiliated Hospital of South China University of Technology

Foshan, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510220, China

Location

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

Location

MeSH Terms

Conditions

Recurrence; Carcinoma, Hepatocellular; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes

Study Officials

• Mingxin Pan, Prof.

  Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingxin Pan, Prof.

CONTACT

+8618928918216; pmxwxy@sohu.com

Jianan Feng

CONTACT

13825522877; 972929217@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: June 10, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-04

Locations

CN (4)