Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-03 @ 1:06 AM
Study NCT ID:
NCT06773260
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-22
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver and Spleen Stiffness to Predict the Presence of Esaphageal Varices in Cirrhotic With Advanced HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': ': to evaluate the accuracy of Liver and Spleen stiffness in predicting the presence of high-risk EV needing treatment (VNT) in cirrhotic patients with aHCC who undergo systemic therapy.', 'timeFrame': 'from 2023 to 2025', 'description': 'The patients at enrolment will be undergoing Upper endoscopy to assess the presence of esophageal or gastric varices and abdominal ultrasound (US) and contextual Liver and Spleen stiffness (LSM and SSM) with both Transient Elastography (FibroScan, Echosens) and a 2D-Shear-Wave Elastosonography to assess the Portal Hypertension (PH) degree; furthermore , biochemical analyses including platelet count (10\\^9/mm3), will also be performed'}], 'secondaryOutcomes': [{'measure': 'Number of upper digestive endoscopies spared and Varices Needing Treatment (VNT) missed according to SSM/Baveno criteria evaluated', 'timeFrame': 'from 2023 to 2025', 'description': 'According to Spleen stiffness measurement (SSM)/Baveno criteria, the number of upper endoscopies spared in patients without high-risk varices will be assessed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCC', 'Liver stiffness', 'Spleen stiffness', 'Esophageal varices', 'Portal Hypertension'], 'conditions': ['Hepatocellular Carcinoma', 'Liver Cirrhosis', 'Portal Hypertension']}, 'descriptionModule': {'briefSummary': 'Elasto-HCC is a prospective, uncontrolled, multicenter observational study involving several hepatology centers in Italy. Patients with liver cirrhosis and advanced hepatocellular carcinoma (HCC) who will need to undergo systemic therapy will be enrolled. Patients in the first phase will undergo measurement of liver and spleen stiffness and upper endoscopic evaluation and will subsequently be followed for 12 months', 'detailedDescription': "Hepatocellular carcinoma (HCC) and clinically significant portal hypertension (CSPH) frequently coexist, affecting cirrhotic individuals' prognosis. Recently it has been confirmed that in cirrhotic patients with favorable Baveno VI consensus (platelets\\>150000/mm3 and liver stiffness measurement (LSM\\<20 kPa) or combined model based on spleen stiffness, endoscopic screening for varices could be avoided. The Portal Hypertension (PH)-related complications in all patients should be avoided and well managed, especially if they have advanced HCC (aHCC) at diagnosis. However, unlike patients without HCC, endoscopy is recommended for those who undergo systemic therapy, even if compatible with favorable Baveno VI consensus . The reasons for this indication derive from the consideration that the presence of HCC could influence the measurement of LSM and platelet count.\n\nTo date, in cirrhotic patients without HCC, according to Baveno VII consensus and the last EASL guidelines for non-invasive tests (NITs), besides LSM, Spleen Stiffness Measurement (SSM) is now considered the most accurate NITs for assessing portal hypertension and predicting the presence of esophageal varices (EVs) and varices needing treatment (VNT).\n\nTo date, no studies have evaluated the accuracy of NITs (LSM/SSM) on patients with advanced HCC (aHCC) who should undergo systemic therapy.\n\nThe study aims to assess the performance of SSM to rule out VNT in patients with aHCC who undergo systemic therapy.\n\nEach center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cirrhotic patients of any etiology with aHCC are scheduled to receive systemic treatment for HCC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 yrs;\n* Cirrhotic patients of any etiology with aHCC scheduled to receive any line of systemic treatment for HCC;\n* Patients are willing and able to give informed consent.\n\nExclusion criteria:\n\n* Presence of splenic, mesenteric, or portal vein thrombosis.\n* Previous placement of TIPS at the time of informed consent.'}, 'identificationModule': {'nctId': 'NCT06773260', 'acronym': 'ELASTO-HCC', 'briefTitle': 'Liver and Spleen Stiffness to Predict the Presence of Esaphageal Varices in Cirrhotic With Advanced HCC', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero Universitaria Policlinico Modena'}, 'officialTitle': 'Assessment of Liver and Spleen Stiffness Measurement (LSM/SSM) Accuracy in Predicting the Presence of Oesophageal Varices Needing Treatment in Cirrhotic Patients With Advanced Hepatocellular Carcinoma (HCC) Who Undergo Systemic Therapy', 'orgStudyIdInfo': {'id': 'AOU Policlinico Modena'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cirrhotic patients with advanced HCC', 'description': 'Cirrhotic patients with advanced HCC requiring systemic therapy will undergo upper endoscopy and measurement of liver and spleen stiffness.', 'interventionNames': ['Diagnostic Test: Liver and Spleen stiffness measurement.']}], 'interventions': [{'name': 'Liver and Spleen stiffness measurement.', 'type': 'DIAGNOSTIC_TEST', 'description': 'The use of spleen stiffness measurement to reduce unnecessary upper digestive endoscopies has never been evaluated in this patient setting.', 'armGroupLabels': ['Cirrhotic patients with advanced HCC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'state': 'Italy', 'country': 'Italy', 'facility': 'UOC Gastroenterologia, Azienda Ospedaliero-Universitaria Policlinico Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bologna', 'state': 'Italy', 'country': 'Italy', 'facility': "UOC Gastroenterologia, IRCCS Policlinico Sant'Orsola, Università di Bologna", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Bologna', 'state': 'Italy', 'country': 'Italy', 'facility': "UOC Medicina interna, malattie epatobiliari e immunoallergologiche, IRCCS Policlinico Sant'Orsola, Università di Bologna", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Bologna', 'state': 'Italy', 'country': 'Italy', 'facility': "UOC Semeiotica Medica, IRCCS Policlinico Sant'Orsola, Università di Bologna", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Napoli', 'state': 'Italy', 'country': 'Italy', 'facility': 'Programma Dipartimentale di I fascia, Malattie del Fegato e delle vie Biliari, Azienda Ospedaliera Universitaria - Federico II, Università degli Studi di Napoli Federico II, Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Novara', 'state': 'Italy', 'country': 'Italy', 'facility': 'Azienda Ospedaliera', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Padua', 'state': 'Italy', 'country': 'Italy', 'facility': 'UOC Clinica Medica 5 - Unit of Internal Medicine and Hepatology, Azienda Ospedale Università Padova,', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Roma', 'state': 'Italy', 'country': 'Italy', 'facility': 'UOC Centro Malattie Apparato Digerente (CEMAD, IRCCS Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore,', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Siena', 'state': 'Italy', 'country': 'Italy', 'facility': 'Dipartimento delle Scienze Mediche,Chirurgiche e Neuroscienze,UNISIEN', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Verona', 'state': 'Italy', 'country': 'Italy', 'facility': 'USD Liver Unit, Azienda Ospedaliera Universitaria Integrata Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '41126', 'city': 'Modena', 'country': 'Italy', 'facility': 'UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'Alessandra Pivetti, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Azienda Ospedaliera Universitaria Policlinico Modena'}, {'name': 'Luigi Colecchia, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria, Bologna'}, {'name': 'Elton Dajti, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria, Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero Universitaria Policlinico Modena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof of Gastroenterology', 'investigatorFullName': 'ANTONIO COLECCHIA', 'investigatorAffiliation': 'Azienda Ospedaliero Universitaria Policlinico Modena'}}}}