NCT06047275

Brief Summary

Hepatitis C diagnostic devices have been developed at the University of Hull to detect and quantify the Hepatitis C virus in patients' plasma and serum samples. This study aims to test the new point-of-care devices that are designed to be low cost and user-friendly. Excess, stored, HCV patients' plasma, serum and blood samples will be supplied by the Virology laboratory (Hull University Teaching Hospital's Trust; HUTH). These samples were taken and analysed as part of patients' clinical monitoring, and are stored prior to disposal in the Virology laboratory. The proposed study will use the samples in a fully anonymised manner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

September 14, 2023

Last Update Submit

July 8, 2024

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Validation of Microfluidic device with serum and plasma

    A new paper and electrochemical microfluidic device was tested with serum and plasma samples from known HCV positive samples and normal controls. The controls allowed a threshold level to be determined and all plasma and serum samples gave positive results and these were correlated with the previously acquired clinical data.

    30 minutes

Study Arms (2)

Test

Hep C positive

Control

Hep C negative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with potential Hep C

You may qualify if:

  • Blood sample taken

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hull

Hull, HU6 7RX, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

May 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

GB(1)