VIRal Hepatitis and GAllstone Disease Study

NCT04222803 | Suspended

• 1 other identifier: VIRGAD
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gallstone Attack; Viral Hepatitis

Outcome Measures

Primary Outcomes (5)

• Association between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease

  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

  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

  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

  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

  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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Södra Älvsborgs Sjukhus

Borås, 501 82, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

9 mL serum will be sampled from each participant in the study.

Study Officials

• Martin Martin, MD PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: October 7, 2022
• Primary Completion (Estimated): October 9, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)