VIRal Hepatitis and GAllstone Disease Study (VIRGAD)

April 7, 2025 updated by: Martin Lagging, MD PhD, Göteborg University

Viral Hepatitis and Gallstone Disease Study

The study aims to investigate possible associations between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Patients seeking care at emergency room at Sahlgrenska University Hospital, Gothenburg, Sweden undergoing ultrasound or computed tomography for suspected gallstone disease, will be asked if they wish to participate in the study. If they agree, a serum sample will be draw for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA. The proportion of patients with vs. without ultrasound or computed tomography-verified gallstone disease will be evaluated regarding possible ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Borås, Sweden, 501 82
        • Södra Älvsborgs Sjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with and without ultrasound or computed tomography-verified gallstone disease will be compared for biomarkers of ongoing viral hepatitis (i.e. anti-HAV IgM, HBsAg, HCV Core antigen and HEV RNA).

Description

Inclusion Criteria:

  • Acute abdominal pain entailing an abdominal ultrasound or computed tomography for suspected gallstone disease at the emergency room at Sahlgrenska University Hospital, Gothenburg
  • Written informed consent
  • Ability to obtain 9 mL serum for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA

Exclusion Criteria:

  • Not willing to give written informed consent
  • Age below 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Association between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease
Time Frame: 1 day
The proportion of patient with verified gallstone disease having detectable anti-HAV IgM, HBsAg, HCV Core antigen or HEV RNA will be compared with the proportion among patients without verified gallstone disease.
1 day
Association between ongoing hepatitis A virus infection and ultrasound or computed tomography-verified gallstone disease
Time Frame: 1 day
The proportion of patient with verified gallstone disease having detectable anti-HAV IgM will be compared with the proportion among patients without verified gallstone disease.
1 day
Association between ongoing hepatitis B virus infection and ultrasound or computed tomography-verified gallstone disease
Time Frame: 1 day
The proportion of patient with verified gallstone disease having detectable HBsAg will be compared with the proportion among patients without verified gallstone disease.
1 day
Association between ongoing hepatitis C virus infection and ultrasound or computed tomography-verified gallstone disease
Time Frame: 1 day
The proportion of patient with verified gallstone disease having detectable HCV Core antigen will be compared with the proportion among patients without verified gallstone disease.
1 day
Association between ongoing hepatitis E virus infection and ultrasound or computed tomography-verified gallstone disease
Time Frame: 1 day
The proportion of patient with verified gallstone disease having detectable HEV RNA will be compared with the proportion among patients without verified gallstone disease.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Göteborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Martin, MD PhD, Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIRGAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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