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

NCT ID: NCT06914635

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-30

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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SARS CoV-2 Liver Tumours

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Recovered subjects after SARS-CoV-2 infection

No interventions assigned to this group

Patients with primary liver tumor.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Mario Mondelli

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mario Mondelli, MD

Role: CONTACT

+390382502639

Barbara Oliviero, Biologist

Role: CONTACT

Facility Contacts

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Mario Mondelli, MD

Role: primary

+39 0382 502639

Barbara Oliviero, Biologist

Role: backup

Other Identifiers

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0047354/23

Identifier Type: -

Identifier Source: org_study_id

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