Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Test

NCT03493763 | Unknown

• 1 other identifier: 5hmc HCC monitoring
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigators aim to find out how plasma 5hmC level changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmC can be used as a biomarker for HCC recurrence monitoring.

Conditions

Hepatocellular Carcinoma

Keywords

Recurrence Monitoring; 5-Hydroxymethylcytosine; Liquid biopsy; Cell-free DNA

Outcome Measures

Primary Outcomes (1)

• Time of hepatocellular carcinoma recurrence

  Time from the day of liver resection to the day of clinical diagnosis of recurrence

  2 years

Secondary Outcomes (3)

• 5hmC level in recurrence-related cfDNA after liver resection

  2 years or until tumor recurrence

• Serum alpha-fetoprotein level after liver resection

  2 years or until tumor recurrence

• Adverse effect of 5hmC blood test

  2 years

Study Arms (1)

serum AFP negative HCC patients

1. Patients who received liver resection within 3 months; 2. Hepatocellular carcinoma confirmed pathologically; 3. Serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy.

Diagnostic Test: 5hmC profile in plasma cell-free DNA after liver resection

Interventions

5hmC profile in plasma cell-free DNA after liver resection DIAGNOSTIC_TEST

Peripheral blood is drawn every 3 months after liver resection for 5hmC test (Time frame: 2 years or until tumor recurrence).

serum AFP negative HCC patients

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population will be selected from patients who have received liver resection in the Liver Surgery Department of Zhongshan hospital.

You may qualify if:

• Patients who received liver resection within 3 months;
• Hepatocellular carcinoma confirmed pathologically;
• Serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy.

You may not qualify if:

• Patients with macroscopic tumor remnants;
• Patients with other diseases which may affect the observation mentioned here;
• Patients with medical history of other malignant tumors;
• Pregnant or nursing women.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma cell-free DNA (cfDNA)

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Jia Fan, MD&PhD

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Jia Fan, MD&PhD

CONTACT

+86 21 64041990; fan.jia@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2018
• First Posted: April 10, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 30, 2020
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)