Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS

NCT06317896 | Not Yet Recruiting DMC

• 1 other identifier: 2024-KY-048-01
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 3

Brief Summary

On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment".

Conditions

Hepatocellular Carcinoma; Circulating Tumor Cell; Recurrence; Surgery

Keywords

Hepatocellular Carcinoma; Circulating Tumor Cell; Recurrence; Dynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence-free survival rate

  percentage of recurrence-free survival 2 years after surgery

  2 years

Secondary Outcomes (2)

• Correlation between CTCs status dynamic changes and relapse

  2 years

• Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA

  2 years

Study Arms (1)

Patient with hepatocellular carcinoma

Patient with hepatocellular carcinoma who can undergo radical resection

Diagnostic Test: circulating tumor cells

Interventions

circulating tumor cells DIAGNOSTIC_TEST

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

Also known as: circulating tumor cell DNA

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 CTCs and CTC-DNA 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 (3)

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

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplastic Cells, Circulating; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Mingxin Pan, Prof.

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingxin Pan, Prof.

CONTACT

+8618928918216; pmxwxy@sohu.com

Zhoubin Feng

CONTACT

19830551997; Fzbin1001@163.com

Study Design

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

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CN (3)