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Hepatitis C Virus InfectionSTATNCT05906459

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

An observational study of Hepatitis C Virus Infection, run by Huashan Hospital at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
Anti-HCV antibody and HCV core antigen testing
How many people
20,000 participants
Where
3 sitesChina
Study dates
26 Jun 2023to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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)

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Termination criteria:
  • 1) Subject asked to withdraw consent.
  • 2) Subjects may suffer adverse impact from the study at investigator's discretion.

Trial locations and contacts

3 sites in 1 country.

Qiran Zhang, M.D. contact

18817875704

qrzhang12@fudan.edu.cn

Yiqi Yu, M.D. contact

13601637563

yyq19890619@126.com

China3 sites, 3 recruiting

  • The First People's Hospital Of YunNan

    Kunming, Yunnan, 650100

    Jiawei Geng, M.D.

    Recruiting

  • The fifth People's Hospital Of Shanghai

    Shanghai, Shanghai Municipality, 200240

    Beizheng Leng, M.D.

    Recruiting

  • Central Hospital of Minhang District, Shanghai

    Shanghai, Shanghai Municipality, 201199

    Zhen Zhao, M.D.

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Anti-HCV antibody and HCV core antigen testing
Keywords
Hepatitis C Virus Infection, Rapid diagnostic tests, RDTs, Anti-HCV antibody, HCV core antigen
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-HCV antibody and HCV core antigen testingDiagnostic test

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion rate of rapid diagnostic processes

    Completion rate of rapid diagnostic processes

    Measured: 1day

Secondary outcomes (4)

  1. The prevalence of HCV infection

    The prevalence of HCV infection in the population attending each center (including physical examination)

    Measured: 1 day

  2. 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).

    Measured: 30 days

  3. Additional time required by the testing process

    Additional time required by the testing process

    Measured: 1 day

  4. 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.)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start26 Jun 2023
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
20,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05906459
Sponsor's protocol ID
STAT
Acronym
STAT
Status last verified
Jul 2023
First submitted
29 May 2023
Last updated
17 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After thesis defense the study will be published internationally to be available for the public.

Publications

  • 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.

    PubMed 29866893

  • 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.

    PubMed 30653562

  • 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.

    PubMed 34227402

  • 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.

    PubMed 25531997

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Virus Infection, run by Huashan Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qiran Zhang, M.D. (18817875704, qrzhang12@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion rate of rapid diagnostic processes (time frame: 1day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05906459, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.

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