Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)

NCT06914635 | Recruiting

• 1 other identifier: 0047354/23
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS CoV-2; Liver Tumours

Outcome Measures

Primary Outcomes (1)

• The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.

  From enrollement to 24 weeks

Study Arms (2)

Recovered subjects after SARS-CoV-2 infection

Patients with primary liver tumor.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Line 1: Recovered subjects from SAS-CoV-2 infection. Line 2: Patients with primary liver tumor

You may qualify if:

• Line 1: - Age \>18 at time of signing informed consent form
• Signed informed consent form Line 2: - Primery liver tumor
• Age \>18 at time of signing informed consent form
• Signed informed consent form

You may not qualify if:

• Line 1: - Active or history of neoplastic malignancy
• Active autoimmune disease ongoing treatment with immunosuppressive therapy
• Evidence of positive HIV, HCV, HBV test
• Diabetes
• Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months
• Chronic autoimmune or inflammatory diseases
• Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies
• 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
• HIV infection
• Failure to sign informed consent form

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Mario Mondelli, MD

CONTACT

+390382502639; m.mondelli@smatteo.pv.it

Barbara Oliviero, Biologist

CONTACT

b.oliviero@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 6, 2025
• Study Start: May 30, 2023
• Primary Completion: February 19, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-03

Locations

IT (1)