Clinical trial NCT05906459: Simplification and Test and Treat Strategies Towards Hepatitis C Eliminationplatform" in China(STAT)
Official title: Establishment of Rapid Diagnostic Procedure of "HCV Single-sample Detection Platform" in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C Virus Infection
Rapid diagnostic tests, RDTs
Anti-HCV antibody
HCV core antigen
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Completion rate of rapid diagnostic processes
timeFrame: 1day
Secondary outcomes:
measure: The prevalence of HCV infection
timeFrame: 1 day
measure: The proportion of abnormal fibroscan results, liver function, blood routine, and ultrasound data in HCV-infected people
timeFrame: 30 days
measure: Additional time required by the testing process
timeFrame: 1 day
measure: The feedback and evaluation from study participants
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The fifth People's Hospital Of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital of Minhang District, Shanghai
state: Shanghai
city: Kunming
country: China
facility: The First People's Hospital Of YunNan
state: Yunnan
Study officials:
affiliation: Huashan Hospital
name: WenHong Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.