Liver CirrhosisNCT06679738
Genetic Variants Associated With the Risk of Gall Stones and Cirrhosis.
An observational study of Liver Cirrhosis and Gall Stone, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Gall Stone
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 10 Nov 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: * Patients > 18 years of age. * Who have either gall stone disease or cirrhosis.
Who may be able to join
- 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.
Who cannot join
- 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.
- Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ananthu Narayan S J, MD, 01146300000, ananthunarayansj@gmail.com
About this study
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.
Read the detailed description
Study population:
- Patients > 18 years of age.
- Who have either gall stone disease or cirrhosis. Study design: All consecutive in-patients and out-patients requiring liver biopsy for evaluation of diffuse parenchymal liver disease will be evaluated for inclusion.
Study period: 1 year. Intervention: Blood sample from included patients will be subject to panel based NGS.
Monitoring and assessment: History of all patients including family history will be taken. Screening for cirrhosis will be done by fibroscan or ultrasound scanning. Gall stone diagnosis is made by USG. History about patients' parents, siblings, spouse, children will be taken with respect to gall stone and cirrhosis. NGS of cholecystitis will be send for the subject and the results will be collected as the fastQ file for analysis.
Statistical Analysis: MVA will be done to identify gene variants independently associated with lithogenesis and cirrhosis, along with demographic and environmental risk factors for these conditions. * From this data, overlapping risk-variants in common associated genes will be identified. A risk estimate (OR with 95% CI) will be calculated for each of the above identified genetic risk variant for the phenotype of cirrhosis with GS.
Adverse effects:
There are no adverse outcomes with respect to this study. Stopping rule of study: There are no stopping rules for the study.
- Conditions
- Liver Cirrhosis, Gall Stone
- Medical subject headings
- Liver Cirrhosis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis with GSD | Cirrhosis with GSD | |
| No cirrhosis with no GSD | No cirrhosis with no GSD | |
| Cirrhosis with no GSD | Cirrhosis with no GSD | |
| GSD with no cirrhosis | GSD with no cirrhosis | |
| Cirrhosis with history of cholecystectomy for GSD | Cirrhosis with history of cholecystectomy for GSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genetic risk-variants associated with both GS and modulation of liver cirrhosis in patients with cirrhosis.
Measured: Day 0
Secondary outcomes (3)
Identification of genetic polymorphisms in bile-acid metabolism and enterohepatic circulation, associated with increased GS risk in patients with cirrhosis.
Measured: Day 0
Identification of genetic polymorphisms in cholesterol metabolism pathway, associated with increased GS risk in patients with cirrhosis.
Measured: Day 0
To study the association of UGT1A1 polymorphisms affecting bilirubin conjugation, with risk of GS in patients with cirrhosis.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679738
- Sponsor's protocol ID
- ILBS-Cirrhosis-67
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variants Associated With the Risk of Gall Stones and Cirrhosis.
- ClinicalTrials.gov ID
- NCT06679738
- Acronym / sponsor ID
- ILBS-Cirrhosis-67
- Conditions
- Liver Cirrhosis, Gall Stone
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study population:
- Patients > 18 years of age.
- Who have either gall stone disease or cirrhosis. Study design: All consecutive in-patients and out-patients requiring liver biopsy for evaluation of diffuse parenchymal liver disease will be evaluated for inclusion.
Study period: 1 year. Intervention: Blood sample from included patients will be subject to panel based NGS.
Monitoring and assessment: History of all patients including family history will be taken. Screening for cirrhosis will be done by fibroscan or ultrasound scanning. Gall stone diagnosis is made by USG. History about patients' parents, siblings, spouse, children will be taken with respect to gall stone and cirrhosis. NGS of cholecystitis will be send for the subject and the results will be collected as the fastQ file for analysis.
Statistical Analysis: MVA will be done to identify gene variants independently associated with lithogenesis and cirrhosis, along with demographic and environmental risk factors for these conditions. * From this data, overlapping risk-variants in common associated genes will be identified. A risk estimate (OR with 95% CI) will be calculated for each of the above identified genetic risk variant for the phenotype of cirrhosis with GS.
Adverse effects:
There are no adverse outcomes with respect to this study. Stopping rule of study: There are no stopping rules for the study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis with GSD | – | –Cirrhosis with GSD |
| No cirrhosis with no GSD | – | –No cirrhosis with no GSD |
| Cirrhosis with no GSD | – | –Cirrhosis with no GSD |
| GSD with no cirrhosis | – | –GSD with no cirrhosis |
| Cirrhosis with history of cholecystectomy for GSD | – | –Cirrhosis with history of cholecystectomy for GSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients > 18 years of age. * Who have either gall stone disease or cirrhosis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of genetic risk-variants associated with both GS and modulation of liver cirrhosis in patients with cirrhosis.
Time frame: Day 0
3 secondary outcomes
Identification of genetic polymorphisms in bile-acid metabolism and enterohepatic circulation, associated with increased GS risk in patients with cirrhosis.
Time frame: Day 0
Identification of genetic polymorphisms in cholesterol metabolism pathway, associated with increased GS risk in patients with cirrhosis.
Time frame: Day 0
To study the association of UGT1A1 polymorphisms affecting bilirubin conjugation, with risk of GS in patients with cirrhosis.
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Gall Stone, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 5 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: opening soon, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ananthu Narayan S J, MD (01146300000, ananthunarayansj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genetic risk-variants associated with both GS and modulation of liver cirrhosis in patients with cirrhosis. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024.