RecruitingNCT06157060

Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA

Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring Minimal Residual Disease Based on Circulating Tumor DNA


Sponsor

Zhujiang Hospital

Enrollment

255 participants

Start Date

Nov 20, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria7

  • 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;
  • Other conditions deemed unsuitable for inclusion by the researcher.

Interventions

DIAGNOSTIC_TESTcirculating tumor DNA

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


Locations(7)

The Sixth Affiliated Hospital of South China University of Technology

Foshan, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Shunde Hospital of Southern Medical University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Yuebei People's Hospital

Shaoguan, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT06157060