A Prospective Study on the Application of Liquid Biopsy in the Surveillance of High-risk Population of HCC.

NCT06134973 | Unknown

• 1 other identifier: Fangwang03
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Liquid biopsy technology based on high-throughput sequencing can detect trace signals in the early stage of cancer in plasma free DNA, so it has become a new technology suitable for tumor diagnosis and screening.Relying on the key discipline of digestive liver disease in our hospital, this project cooperated with BGI to jointly carry out a prospective study on the application of liquid biopsy in the monitoring of population at risk of liver cancer by taking advantage of its technical advantages in next-generation sequencing, so as to provide an innovative way for the prevention and treatment of Hepatocellular Carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Liquid biopsy; ultrasonic testing

Outcome Measures

Primary Outcomes (2)

• The establishment of risk assessment model

  The risk assessment model of liver cancer was established to identify the high-risk groups of HCC.

  6-12 months

• Application prospect of liquid biopsy technique in monitoring HCC in high risk population

  To evaluate the potential application of liquid biopsy techniques for liver cancer surveillance in high-risk populations through a prospective cohort

  12-24 months

Study Arms (2)

Nodular group

nodules less than 2 cm in diameter

Diagnostic Test: ultrasonic testing

Macronodular group

nodules between 2-3 cm in diameter

Diagnostic Test: ultrasonic testing

Interventions

ultrasonic testing DIAGNOSTIC_TEST

ultrasonic testing

Macronodular group; Nodular group

Eligibility Criteria

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

Study Population

Enrollment criteria: All patients who were admitted to our hospital over 18 years old and found intrahepatic nodules by abdominal ultrasound and consented to join the prospective cohort study of intrahepatic nodules monitoring. Enrolled patients were grouped according to the maximum diameter of nodules in the live and were divided into nodular group (diameter less than 2 cm) and macronodular group (diameter 2-3 cm). Outcome events: Intrahepatic nodules were diagnosed as cancerous nodules. Follow-up: Patients who found intrahepatic nodules but were not confirmed by imaging or pathology were followed up every 2-3 months with imaging combined with serum AFP levels until the outcome events were observed.

You may qualify if:

• Patients diagnosed as chronic liver disease, including but not limited to chronic hepatitis B, chronic hepatitis C, fatty liver;
• Intrahepatic nodules detectable by ultrasound;
• Unlimited number of nodules;
• The patient has signed an informed consent form.

You may not qualify if:

• Previously diagnosed malignant tumors；
• Patients who are unable to cooperate with venous blood sampling；
• According to the judgment of the investigator, the participants are not suitable to participate in this study.

Sponsors & Collaborators

• Tianjin Third Central Hospital: lead
• BGI, China: collaborator

Study Sites (1)

王芳

Tianjin, Tianjin Municipality, 300170, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

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

• Fengmei Wang, PhD

  Tianjin Third Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengmei Wang, PhD

CONTACT

15522242696; wangfengmeitj@126.com

Fang Wang, MD

CONTACT

+8618649047892; yaoywang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)