Effectiveness of mRNA Covid-19 Vaccines on Cancer Patients:Observational Study. (ANTICOV)

NCT04878796 | Unknown DMC

• 1 other identifier: ASST CR-01-2021
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Based on recent data, COVID (COV) vaccination in cancer patients (pts) is strictly recommended. For oncologic pts,2 types of m-RNA vaccines have been approved: BNT162b2 (Pfizer, Biontech) and mRNA-1273 (Moderna, NIAID). In immunocompetent population, the administration of 2 doses confers 95% protection against COV. However, protection conferred by vaccines, adverse events (AEs) and correlations with antiblastic treatments are unknown in cancer pts.

Conditions

Cancer; Covid-19; Vaccine Response

Keywords

Cancer treatment; Covid-19; Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of symptomatic patients affected by COVID-19

  Evaluating the protection conferred by vaccination, by detecting the number of symptomatic pts affected by COV, diagnosed 7-60 days after the 2nddose of vaccine. Confirmed of COV infection is defined according to the Food and Drug Administration criteria combined with a nasopharyngeal swab, positive for SARS-Cov-2, obtained during the symptomatic period or within 4 days before or after it.

  7-60 days after the 2nd dose of vaccine

Secondary Outcomes (2)

• Antibodies variation at different timepoints

  baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine

• Adverse Events and interference between vaccine and cancer treatments

  from 7 to 90 days after the 2nd dose of vaccine

Interventions

Serum collection, adverse events collection DIAGNOSTIC_TEST

Measuring Abs variation at different timepoints compared to baseline. LIAISON SARS-Cov-2 TrimericS IgG and Elecsys anti-SARS-Cov-2 tests will be adopted. The level of Abs will be evaluated at baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients receiving active therapy (chemotherapy, immonotherapy, target therapy, radiotherapy, hormonal therapy ) or who have completed their oncologic treatment within 6 months and have been prescribed the administration of the admRNAanti-COVID-19 vaccine

You may qualify if:

• Cancer patients receiving active therapy (chemotherapy, immunotherapy, target therapy, radiotherapy)
• Cancer patients receiving hormonal therapy for metastatic disease.
• Must be ≥18 years of age.
• Written, signed consent for study participation.

You may not qualify if:

• Cancer patients receiving hormonal therapy in adjuvant regimen.
• Patients in follow-up and who have completed their cancer treatment for \> 6 months.
• Life expectancy less than 3 months.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Cremona: lead

Study Sites (1)

UO Oncologia, ASST di Cremona

Cremona, Lombardy, 26100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MARGHERITA RATTI, MD

  Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARGHERITA RATTI, MD

CONTACT

+390372408035; margherita.ratti@asst-cremona.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: May 24, 2021
• Primary Completion: October 1, 2021
• Study Completion: May 1, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-05

Locations

IT (1)