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

Hepatitis C Virus Infection Clinical Trial

— STAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906459
• Other study ID #: STAT
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Huashan Hospital
• Contact: Qiran Zhang, M.D.
• Phone: 18817875704
• Email: qrzhang12[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Diagnostic Test:
• Anti-HCV antibody and HCV core antigen testing
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.

Locations

Country	Name	City	State
China	The First People's Hospital Of YunNan	Kunming	Yunnan
China	Central Hospital of Minhang District, Shanghai	Shanghai	Shanghai
China	The fifth People's Hospital Of Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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 screen — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of rapid diagnostic processes	Completion rate of rapid diagnostic processes	1day
Secondary	The prevalence of HCV infection	The prevalence of HCV infection in the population attending each center (including physical examination)	1 day
Secondary	The proportion of abnormal fibroscan results, liver function, blood routine, and ultrasound data in HCV-infected people	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
Secondary	Additional time required by the testing process	Additional time required by the testing process	1 day
Secondary	The feedback and evaluation from study participants	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

External Links

•   Comparison between Colloidal Gold and Enzyme-linked Immunosorbent Assay of Hepatitis C Virus Antibody
•   Guidelines for the prevention and treatment of hepatitis C (2019 version)