Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active.

NCT ID: NCT06334744

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2023-06-08

Brief Summary

To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine.

Conditions

Oncologic Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 years or older, regardless of gender;

2. Life expectancy (estimated by the treating doctor) ≥ 6 months;

3. Histological diagnosis confirmed solid neoplasm;

4. Under active treatment

5. Previous two doses of Pfizer anti-SARS-CoV-2 vaccine received (will be considered also patients who have completed the vaccination cycle with other mRNA vaccines - Modern-)

6. All participants subscribed and signed the informed consent form first of enlistment

7. Patients with a positive history of a previous diagnosis are also enrolled laboratory confirmed COVID-19

8. ECOG 0-2

Exclusion Criteria

1. Inability to sign informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Irccs San Matteo Pavia

Pavia, PV, Italy

Countries

Italy

Other Identifiers

COVAR

Identifier Type: -

Identifier Source: org_study_id