Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-01 @ 3:37 AM
Study NCT ID:
NCT05335603
Status:
RECRUITING
Last Update Posted:
2022-04-19
First Post:
2022-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D019693', 'term': 'Hepatitis, Autoimmune'}, {'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}, {'id': 'D006432', 'term': 'Hemochromatosis'}, {'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D019190', 'term': 'Iron Overload'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Liver tissue, plasma, serum, whole blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 335}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2036-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2036-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fibrosis stage of the liver', 'timeFrame': '10 years', 'description': 'Non-invasive scoring systems (e.g. Fibroscan, Fib-4)'}], 'primaryOutcomes': [{'measure': 'Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.', 'timeFrame': '10 years', 'description': 'OMICS based analyses on plasma and liver tissue'}], 'secondaryOutcomes': [{'measure': 'To identify any metabolic disturbances within chronic liver diseases', 'timeFrame': 'Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.', 'description': 'Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-alcoholic fatty liver disease', 'non-alcoholic steatohepatitis', 'steatosis', 'autoimmune hepatitis', 'primary biliary cholangitis', 'primary sclerosing cholangitis', 'haemochromatosis', 'alfa-1-antitrypsin deficiency', 'chronic pancreatitis', 'chronic liver disease', 'inflammatory bowel disease', 'OMICS', 'Mass spectrometry'], 'conditions': ['Chronic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '40671462', 'type': 'DERIVED', 'citation': 'Jensen AH, Ytting H, Nielsen AB, Werge MP, Rashu EB, Hetland LE, Thing M, Nabilou P, Burisch J, Junker AE, Hobolth L, Mortensen C, Tofteng F, Bendtsen F, Moller S, Vyberg M, Serizawa RR, Winther-Sorensen M, Kellemann JS, Gluud LL, Wewer Albrechtsen NJ. Diagnostics of Autoimmune Hepatitis Enabled by Non-Invasive Clinical Proteomics. Aliment Pharmacol Ther. 2025 Nov;62(9):901-919. doi: 10.1111/apt.70273. Epub 2025 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potentially eligible patients will be identified and recruited among those referred with suspected liver disease at the outpatient clinic at the Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark. Healthy control participants will be recruited through advertisements at forsoegsperson.dk and posters. Posters will be mounted in neutral places at Copenhagen University Hospital Hvidovre and at neutral places at the Panum Institute. Copenhagen University Hospital Hvidovre is a large regional hospital with more than 3500 employees and the Panum Institute is a large building complex in Copenhagen, Denmark that houses the Faculty of Health and Medical Sciences.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients/healthy control participants (age 18 or above) who can give their informed consent\n* Suspected liver disease:\n* non-alcoholic steatohepatitis\n* alcoholic steatohepatitis\n* autoimmune hepatitis\n* primary biliary cholangitis\n* primary sclerosing cholangitis\n* inflammatory bowel disease\n* polycystic ovary syndrome\n* hereditary haemochromatosis\n* chronic pancreatitis\n* cystic fibrosis\n* alpha-1 antitrypsin deficiency\n\nExclusion Criteria:\n\nPatients with:\n\n* malignant diseases\n* viral hepatitis\n* human immunodeficiency virus\n* contraindications to liver biopsy'}, 'identificationModule': {'nctId': 'NCT05335603', 'acronym': 'FALL', 'briefTitle': 'An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis', 'orgStudyIdInfo': {'id': 'FALL'}}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne-Sofie H Jensen, MD', 'role': 'CONTACT', 'email': 'anne-sofie.houlberg.jensen@regionh.dk', 'phone': '+4538621966'}, {'name': 'Lise L Gluud, Professor', 'role': 'CONTACT', 'email': 'lise.lotte.gluud.01@regionh.dk', 'phone': '+4538621964'}], 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Anne-Sofie H Jensen, MD', 'role': 'CONTACT', 'email': 'anne-sofie.houlberg.jensen@regionh.dk', 'phone': '+4538621966'}, {'name': 'Lise L Gluud, Professor', 'role': 'CONTACT', 'email': 'lise.lotte.gluud.01@regionh.dk', 'phone': '+4538621964'}], 'overallOfficials': [{'name': 'Lise L Gluud, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}, {'name': 'Nicolai J Wewer Albrechtsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NNF Center for Protein Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hvidovre University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Nicolai Jacob Wewer Albrechtsen', 'investigatorAffiliation': 'University of Copenhagen'}}}}