Simplification and Test and Treat Strategies Towards Hepatitis C Eliminationplatform" in China(STAT)
STAT
Establishment of Rapid Diagnostic Procedure of "HCV Single-sample Detection Platform" in China
1 other identifier
observational
20,000
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 17, 2023
July 1, 2023
6 months
May 29, 2023
July 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Completion rate of rapid diagnostic processes
Completion rate of rapid diagnostic processes
1day
Secondary Outcomes (4)
The prevalence of HCV infection
1 day
The proportion of abnormal fibroscan results, liver function, blood routine, and ultrasound data in HCV-infected people
30 days
Additional time required by the testing process
1 day
The feedback and evaluation from study participants
1 day
Interventions
HCV antibody screening were carried out with rapid diagnostic testings (RDTs) by colloidal gold method, using fingertip blood or residual blood from other testings. For samples with positive HCV antibody RDTs screening results, HCV core antigen detection will be carried out subsequently as diagnostic test. HCV core antigen detection will be conducted with chemiluminescent particle immunoassay using residual blood from other testings.
Eligibility Criteria
This study plans to screen 20,000 subjects for anti-HCV from multiple centers across the country (including those who have physical examinations)
You may qualify if:
- \) 18 years of age and older, regardless of age or gender.
- \) The residual blood sample needs to be not less than 1ml.
- \) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
You may not qualify if:
- \) Pregnant, lactating female and who is planning pregnancy during study period.
- \) History of tumor or other severe, life-threating diseases.
- \) Samples not meet collection requirements.
- \) repeated enrollment.
- \) HCV infection has been diagnosed.
- \) Recent HCV RNA testing confirmed that there is no HCV infection.
- Termination criteria:
- \) Subject asked to withdraw consent.
- \) Subjects may suffer adverse impact from the study at investigator's discretion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (3)
The fifth People's Hospital Of Shanghai
Shanghai, Shanghai Municipality, 200240, China
Central Hospital of Minhang District, Shanghai
Shanghai, Shanghai Municipality, 201199, China
The First People's Hospital Of YunNan
Kunming, Yunnan, 650100, China
Related Publications (4)
Shah H, Bilodeau M, Burak KW, Cooper C, Klein M, Ramji A, Smyth D, Feld JJ; Canadian Association for the Study of the Liver. The management of chronic hepatitis C: 2018 guideline update from the Canadian Association for the Study of the Liver. CMAJ. 2018 Jun 4;190(22):E677-E687. doi: 10.1503/cmaj.170453. No abstract available.
PMID: 29866893RESULTMane A, Sacks J, Sharma S, Singh H, Tejada-Strop A, Kamili S, Kacholia K, Gautam R, Thakar M, Gupta RS, Gangakhedkar R. Evaluation of five rapid diagnostic tests for detection of antibodies to hepatitis C virus (HCV): A step towards scale-up of HCV screening efforts in India. PLoS One. 2019 Jan 17;14(1):e0210556. doi: 10.1371/journal.pone.0210556. eCollection 2019.
PMID: 30653562RESULTChevaliez S, Roudot-Thoraval F, Hezode C, Pawlotsky JM, Njouom R. Performance of rapid diagnostic tests for HCV infection in serum or plasma. Future Microbiol. 2021 Jul;16:713-719. doi: 10.2217/fmb-2020-0295. Epub 2021 Jul 6.
PMID: 34227402RESULTFlorea D, Neaga E, Nicolae I, Maxim D, Popa M, Otelea D. Clinical usefulness of HCV core antigen assay for the management of patients with chronic hepatitis C. J Gastrointestin Liver Dis. 2014 Dec;23(4):393-6. doi: 10.15403/jgld.2014.1121.234.chcv.
PMID: 25531997RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
WenHong Zhang, M.D.
Huashan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Division of Infectious Diseases Affiliation: Huashan Hospital
Study Record Dates
First Submitted
May 29, 2023
First Posted
June 15, 2023
Study Start
June 26, 2023
Primary Completion
December 30, 2023
Study Completion
June 30, 2024
Last Updated
July 17, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available within four year
- Access Criteria
- Not yet
After thesis defense the study will be published internationally to be available for the public.