Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-02 @ 2:55 AM
Study NCT ID:
NCT06914635
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.', 'timeFrame': 'From enrollement to 24 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS CoV-2', 'Liver Tumours']}, 'descriptionModule': {'briefSummary': 'The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Line 1: Recovered subjects from SAS-CoV-2 infection. Line 2: Patients with primary liver tumor', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nLine 1: - Age \\>18 at time of signing informed consent form\n\n* Signed informed consent form Line 2: - Primery liver tumor\n* Age \\>18 at time of signing informed consent form\n* Signed informed consent form\n\nExclusion Criteria:\n\nLine 1: - Active or history of neoplastic malignancy\n\n* Active autoimmune disease ongoing treatment with immunosuppressive therapy\n* Evidence of positive HIV, HCV, HBV test\n* Diabetes\n* Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months\n* Chronic autoimmune or inflammatory diseases\n* Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies\n* Other extrahepatic neoplasms occurring or in the last 3 years except for tumors resected with curative intent and without evidence of relapse for \\>3 years prior to signing informed consent and considered low risk of relapse\n* HIV infection\n* Failure to sign informed consent form'}, 'identificationModule': {'nctId': 'NCT06914635', 'briefTitle': 'Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)', 'orgStudyIdInfo': {'id': '0047354/23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recovered subjects after SARS-CoV-2 infection'}, {'label': 'Patients with primary liver tumor.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Mondelli, MD', 'role': 'CONTACT', 'email': 'm.mondelli@smatteo.pv.it', 'phone': '+39 0382 502639'}, {'name': 'Barbara Oliviero, Biologist', 'role': 'CONTACT', 'email': 'b.oliviero@smatteo.pv.it'}], 'facility': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Mario Mondelli, MD', 'role': 'CONTACT', 'email': 'm.mondelli@smatteo.pv.it', 'phone': '+390382502639'}, {'name': 'Barbara Oliviero, Biologist', 'role': 'CONTACT', 'email': 'b.oliviero@smatteo.pv.it'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mario Mondelli', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}