Clinical trial · Observational
Effectiveness of mRNA Covid-19 Vaccines on Cancer Patients:Observational Study. (ANTICOV)
Observational Study to Monitor the Effects of the COVID-19 Vaccine on Cancer Patients Receiving Active Therapy (ANTICOV).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Covid-19 | — | UNRESOLVED | — |
| Vaccine Response | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serum collection, adverse events collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of symptomatic patients affected by COVID-19
- timeFrame
- 7-60 days after the 2nd dose of vaccine
- description
- 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.
Secondary outcomes (2)
- measure
- Antibodies variation at different timepoints
- timeFrame
- baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine
- description
- Two tests are used: LIAISON SARS-Cov-2 TrimericSIgG and Elecsys anti-SARS-Cov-2; The combined use of the two dosages in this vaccinated population will allow an assessment of the pre-vaccine immunological status and the characterization of the antibodies produced after the vaccination stimulus
- measure
- Adverse Events and interference between vaccine and cancer treatments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available