Prospective Cohort Study of Disease and Outcomes in Cirrhosis

NCT04422223 | Unknown DMC

• 1 other identifier: H-19024348
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

A population based incidence cohort will enroll patients newly diagnosed with cirrhosis to investigate disease characteristics and outcomes, explore mechanisms predicting early death and hospital admission, and assess new monitoring tools in treatment and prevention of cirrhosis.

Conditions

Liver Cirrhosis, Alcoholic; Progression; Liver Diseases; Decompensated Cirrhosis

Keywords

Prognosis; Prospective; Cirrhosis; Hepatology

Outcome Measures

Primary Outcomes (2)

• Improve risk of decompensation in cirrhosis

  time to development of decompensation

  5 years

• Survival

  Time from diagnosis to death or liver transplantation

  5 years

Secondary Outcomes (4)

• Risk prediction by Short Physical Performance Battery

  5 years

• Characterization of patients

  5 years

• Social impact of cirrhosis

  5 years

• Life space Assessment

  5 years

Study Arms (1)

Cohort

Patients newly diagnosed with liver cirrhosis form the Gastro Unit, Amager Hvidovre Hospital, Denmark. All patients with clinically verified diagnosis, irrepsective of disease stage and etiology is included.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a debut of liver cirrhosis, irrespective of time and circumstances of diagnosis, comorbidities and severity of disease will be offered inclusion in the cohort. A small percentage of patients will be diagnosed with cirrhosis at a very late stage of disease and have complications compromising their cognitive function. When complications are considered reversible, enrolment in the study will be sought when the patient has recovered. When complications are considered irreversible or there may be reasonable doubt of the patient's survival, patients will be considered eligible, but excluded to avoid unethical conduction of procedures. Participants may be diagnosed with terminal disease or end-stage liver disease. In such a case, to secure the integrity of the patient, no extra investigational procedures will be made and only data sampled in standard medical care will be used in the cohort database.

You may qualify if:

• Clinical suspicion of cirrhosis supported by biochemistry and ultrasound or other imaging techniques.
• Cirrhosis of any etiology
• Informed written consent

You may not qualify if:

• People where the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging.
• Withdrawal of informed consent or no informed consent.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• University of Copenhagen: collaborator

Study Sites (1)

Nina Kimer

Hvidovre, Please Enter the State Or Province, 2650, Denmark

RECRUITING

Related Publications (1)

• Mynster Kronborg T, Webel H, O'Connell MB, Danielsen KV, Hobolth L, Moller S, Jensen RT, Bendtsen F, Hansen T, Rasmussen S, Juel HB, Kimer N. Markers of inflammation predict survival in newly diagnosed cirrhosis: a prospective registry study. Sci Rep. 2023 Nov 16;13(1):20039. doi: 10.1038/s41598-023-47384-2.

  PMID: 37973887 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and buffy coat from whole blood, liver biopsies, stool samples

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic; Disease Progression; Liver Diseases; Fibrosis

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Digestive System Diseases; Liver Diseases, Alcoholic; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Disease Attributes

Central Study Contacts

Nina Kimer, PhD

CONTACT

+4538621968; nina.kimer@regionh.dk

LIse Hobolth, PhD

CONTACT

lise.hobotlh@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: November 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5-10 years

Locations

DK (1)