Simplification and Test and Treat Strategies Towards Hepatitis C Eliminationplatform" in China(STAT) (STAT)

July 13, 2023 updated by: Wen-hong Zhang, Huashan Hospital

Establishment of Rapid Diagnostic Procedure of "HCV Single-sample Detection Platform" in China

The present study aims to establish a " one-sample testing platform " and assess the prevalence of hepatitis C in individuals taking routine physical examination or outpatient visit in mainland China.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators intend to establish a one-sample testing platform to improve diagnosis and linkage to care process in participants under routine physical examination or outpatient visit. The platform is based on rapid diagnostic tests (RDTs) for HCV screening and HCV core antigen for confirmation. RDTs was used to screen for anti-HCV antibodies. The result of RDT will be interpreted within 15 minutes with the sensitivity of 98.9% (95%CI, 94.5% to 99.8%) and specificity of 98.9% (95%CI, 97.5% to 99.9%) using whole blood or finger-stick blood sample [3-5]. HCV core antigen is a marker of HCV replication and has a good correlation with HCV RNA in HCV-positive patients (R=0.98). A recent study suggested HCV core antigen testing could be used alternative testing for HCV RNA testing for diagnosis when HCV RNA testing was unavailable. The process of HCV core antigen test only takes 2-3 hours. "one-sample" means only one drop (10ul) of finger-stick blood or residual blood samples from other routine tests collected from patients was needed for anti-HCV antibody testing and HCV core antigen testing, which means they will not have to take another venepuncture. In addition, the use of RDT and HCV core antigen are also less costly. This approach might improve access to care, particularly in low-income and middle-income countries.

The present study aims to establish a " one-sample testing platform " in several medical institution to assess the prevalence of hepatitis C in individuals taking routine physical examination and further promote rapid diagnosis platform in mainland China, so as to achieve the goal in 2030.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200240
        • Recruiting
        • The Fifth People's Hospital of Shanghai
        • Contact:
          • Beizheng Leng, M.D.
      • Shanghai, Shanghai, China, 201199
        • Recruiting
        • Central Hospital of Minhang District, Shanghai
        • Contact:
          • Zhen Zhao, M.D.
    • Yunnan
      • Kunming, Yunnan, China, 650100
        • Recruiting
        • The First People's Hospital of Yunnan
        • Contact:
          • Jiawei Geng, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study plans to screen 20,000 subjects for anti-HCV from multiple centers across the country (including those who have physical examinations)

Description

Inclusion Criteria:

  • 1) 18 years of age and older, regardless of age or gender.
  • 2) The residual blood sample needs to be not less than 1ml.
  • 3) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion Criteria:

  • 1) Pregnant, lactating female and who is planning pregnancy during study period.
  • 2) History of tumor or other severe, life-threating diseases.
  • 3) Samples not meet collection requirements.
  • 4) repeated enrollment.
  • 5) HCV infection has been diagnosed.
  • 6) Recent HCV RNA testing confirmed that there is no HCV infection.

Termination criteria:

  • 1) Subject asked to withdraw consent.
  • 2) Subjects may suffer adverse impact from the study at investigator's discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion rate of rapid diagnostic processes
Time Frame: 1day
Completion rate of rapid diagnostic processes
1day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of HCV infection
Time Frame: 1 day
The prevalence of HCV infection in the population attending each center (including physical examination)
1 day
The proportion of abnormal fibroscan results, liver function, blood routine, and ultrasound data in HCV-infected people
Time Frame: 30 days
For example, the confirmed rate of HCV infection in the screening population was much higher than that of HCV infection in the region in the epidemiological survey, and the degree of liver fibrosis and cirrhosis assessed by the confirmed population through this process was significantly lower than the mean HCV population reported in the literature, which indirectly reflected the potential benefit of rapid diagnosis process in helping to detect HCV infection missed in routine visits (including physical examination).
30 days
Additional time required by the testing process
Time Frame: 1 day
Additional time required by the testing process
1 day
The feedback and evaluation from study participants
Time Frame: 1 day
Feedback and assessments of study participants were collected using the Clinical Trial Participant Satisfaction Questionnaire (including whether it affects routine visits (including physical examination) procedures, and the acceptance of this process, etc.)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Wenhong Zhang, M.D., Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After thesis defense the study will be published internationally to be available for the public.

IPD Sharing Time Frame

Data will be available within four year

IPD Sharing Access Criteria

Not yet

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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