Testing platform for hepatitis C diagnosis in China
Establishment of Rapid Diagnostic Procedure of "HCV Single-sample Detection Platform" in China
This study is testing a quick and easy blood test for hepatitis C to help people in China get diagnosed and linked to care faster during their routine check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 3 sites (Shanghai, Shanghai and 2 other locations) |
| Trial ID | NCT05906459 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a one-sample testing platform to improve the diagnosis and care linkage for hepatitis C in individuals undergoing routine physical examinations or outpatient visits in mainland China. It utilizes rapid diagnostic tests (RDTs) for screening anti-HCV antibodies and HCV core antigen for confirmation, allowing results to be interpreted within 15 minutes. The platform requires only a small blood sample, minimizing the need for additional venepuncture and reducing costs, which could enhance access to care, especially in low- and middle-income countries.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and older who are undergoing routine physical examinations or outpatient visits and can provide a residual blood sample.
Not a fit: Patients who are pregnant, have a history of severe diseases, or have already been diagnosed with HCV infection will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the early detection and treatment of hepatitis C, leading to better health outcomes for patients.
How similar studies have performed: Other studies have shown success with similar rapid diagnostic approaches for hepatitis C, indicating potential for this method to be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai and 2 other locations
- The fifth People's Hospital Of Shanghai — Shanghai, Shanghai, China (Recruiting)
- Central Hospital of Minhang District, Shanghai — Shanghai, Shanghai, China (Recruiting)
- The First People's Hospital Of YunNan — Kunming, Yunnan, China (Recruiting)
Study contacts
- Principal investigator: WenHong Zhang, M.D. — Huashan Hospital
- Study coordinator: Qiran Zhang, M.D.
- Email: qrzhang12@fudan.edu.cn
- Phone: 18817875704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.