NCT05906459|Unknown
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
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STAT
Establishment of Rapid Diagnostic Procedure of "HCV Single-sample Detection Platform" in China
Sponsor study identifier
observational
20,000
1 country
3
Study Start
June 26, 2023
Actual (reported)Primary Completion
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 29, 2023
Actual (reported)June 15, 2023
Actual (reported)June 26, 2023
Actual (reported)December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Completion rate of rapid diagnostic processes
Completion rate of rapid diagnostic processes
1day
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This study plans to screen 20,000 subjects for anti-HCV from multiple centers across the country (including those who have physical examinations)
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
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.
Mane 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.
WenHong Zhang, M.D.
Huashan Hospital
First Submitted
May 29, 2023
First Posted
June 15, 2023
Study Start
June 26, 2023
Actual (reported)Primary Completion
December 30, 2023
Estimated (date passed)Hepatitis C Tracker Study
Contact the study team to confirm eligibility.
Chevaliez 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.
Florea 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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 17, 2023
Record last verified: 2023-07
After thesis defense the study will be published internationally to be available for the public.
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Source: ClinicalTrials.gov.
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