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

NCT ID: NCT05906459

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2024-06-30

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.

Conditions

Hepatitis C Virus Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen-hong Zhang

Director of Division of Infectious Diseases Affiliation: Huashan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

WenHong Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

The fifth People's Hospital Of Shanghai

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Central Hospital of Minhang District, Shanghai

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

The First People's Hospital Of YunNan

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiran Zhang, M.D.

Role: CONTACT

qrzhang12@fudan.edu.cn

18817875704

Yiqi Yu, M.D.

Role: CONTACT

yyq19890619@126.com

13601637563

Facility Contacts

Beizheng Leng, M.D.

Role: primary

Zhen Zhao, M.D.

Role: primary

Jiawei Geng, M.D.

Role: primary

References

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.

Reference Type: RESULT

PMID: 29866893 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30653562 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34227402 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25531997 (View on PubMed)

Related Links

http://www.lcgdbzz.org/custom/news/id/10075

Guidelines for the prevention and treatment of hepatitis C (2019 version)

https://gffhc975c3444c2dc4daasn9xfkk5n6p6v6xocfffi.res.gxlib.org.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwNDI2Eg95bGJqcWoyMDExMDUwMjkaCHg0aDN5Znoz

Comparison between Colloidal Gold and Enzyme-linked Immunosorbent Assay of Hepatitis C Virus Antibody

Other Identifiers

STAT

Identifier Type: -

Identifier Source: org_study_id