Hepatocellular Cancer (HCC) Screening in Zhongshan City

NCT02501980 | Unknown

• 1 other identifier: HCC-PRO-001
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

All participants in the selected communities will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. High risk group will be selected according to the definition. HCC diagnosis will be determined according to imaging and/or biopsy result. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group. All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.

Conditions

Liver Neoplasms

Keywords

Screening; Hepatocellular Cancer; Biomarker; Mortality rate

Outcome Measures

Primary Outcomes (1)

• 5-year HCC specific mortality rate

  To reduce 5-year HCC specific mortality rate compare with that of general population

  10 years

Secondary Outcomes (2)

• Early diagnosis rate of HCC

  5 years

• Identification of early diagnosis markers of HCC

  5 years

Study Arms (2)

Screening

All participants will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.

Biological: Biomarker testing and Ultrasonography

Non-screening

All subjects in this arm will be followed by linkage to Cancer Register and Population Register.

Interventions

Biomarker testing and Ultrasonography BIOLOGICAL

Screening

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy residences in Zhongshan City.

You may qualify if:

• Residences in Zhongshan City
• Have no medical records of hepatocellular cancer
• ECOG 0-2
• Provide written informed consent forms
• Have a good physical and psychological condition

You may not qualify if:

• Have severe cardiovascular or kidney disease
• Have medical records of hepatocellular cancer

Sponsors & Collaborators

• Zhongshan People's Hospital, Guangdong, China: lead

Study Sites (1)

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Liver Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Mingfang Ji, MD

  Zhongshan People's Hospital, Guangdong, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mingfang Ji

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: July 17, 2015
• Study Start: January 1, 2012
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

CN (1)