Genetic Variants Associated With the Risk of Gall Stones and Cirrhosis.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India
About this trial
Gall stone disease is more common in patients with cirrhosis. This association has been well established in different studies. Among the various factors which predispose a patient with gall stone disease to have associated liver cirrhosis, genetics also plays an important role.
This study aims to do a genetic panel-based analysis of genes which are involved in cholestasis to find any association between liver cirrhosis and gall stone disease.
Patients with history of gall stone or history of cholecystectomy done for gall stone disease will be evaluated for the presence of liver cirrhosis by fibroscan and ultrasonography. Those patients with cirrhosis and without cirrhosis will undergo a panel based genetic test for the common cholestasis genes and multivariate analysis will be done for variants associated with lithogenesis and cirrhosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients > 18 years of age.
Who has a GSD diagnosed by USG or have history of cholecystectomy for gall stone disease.
Who is a diagnosed case of cirrhosis by Fibroscan or USG (Cirrhosis including alcohol related cirrhosis, Hepatitis B, Hepatitis C, Wilsons disease, Hemochromatosis are excluded.
Disqualifiers
Patients who have haemolytic anaemia
Patients who do not consent for genetic study
Patients who has a diagnosed cause for liver disease, including alcohol related cirrhosis, Hepatitis B, Hepatitis C, Wilsons disease, Hemochromatosis.
Inability to provide informed consent.
Trial population
* Patients \> 18 years of age. * Who have either gall stone disease or cirrhosis.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 5 trial groupsGroup A: Cirrhosis with GSD
Group B: No cirrhosis with no GSD
Group C: Cirrhosis with no GSD
Group D: GSD with no cirrhosis
Group E: Cirrhosis with history of cholecystectomy for GSD
Trial outcomes
Primary outcomes
1
Identification of genetic risk-variants associated with both GS and modulation of liver cirrhosis in patients with cirrhosis.
Time frame
Day 0Secondary outcomes
1
Identification of genetic polymorphisms in bile-acid metabolism and enterohepatic circulation, associated with increased GS risk in patients with cirrhosis.
Time frame
Day 02
Identification of genetic polymorphisms in cholesterol metabolism pathway, associated with increased GS risk in patients with cirrhosis.
Time frame
Day 03
To study the association of UGT1A1 polymorphisms affecting bilirubin conjugation, with risk of GS in patients with cirrhosis.
Time frame
Day 0Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: