Clinical trial · Observational
A Study on the Immune-response to COVID-19 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
NCT04800146CI-TRIAL-00064946completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a single centre prospective observational study to assess the immune response to SARS-CoV-2 vaccines in cancer patients receiving active treatment or in follow-up at the IOSI and in non-cancer patients (age and gender matched).
Conditions
Conditions (2)
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 |
| Covid19 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- label
- Cohort 1
- description
- patients with solid tumors treated with chemotherapy (ongoing or completed no more than 6 months before enrollment). Specific type of chemotherapy inducing similar immunosuppression will be selected (including but not limited to platinum-based combinations, anthracycline combinations, triweekly docetaxel).
- interventionNames
- Procedure: Blood sample
- label
- Cohort 2
- description
- patients with solid tumors treated with single agent immune-check points inhibitors (ongoing or completed no more than 6 months before the enrollment
- interventionNames
- Procedure: Blood sample
- label
- Cohort 3
- description
- patients with solid tumors treated with hormonal agents (ongoing or completed no more than 6 months before enrollment): any anti-androgen for prostate cancer and any anti-estrogen for breast cancer patients.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Male of Female age at least 18 years * Patients with a diagnosis of malignancy (solid tumors or hematological malignancies) according to the defined cohorts. Only for cohorts 1-7 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Absence of known immune deficiency (other than cancer for cohorts 1-7) * Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure * Willing and able to comply with the study procedures. * Willing to receive an mRNA anti-SARS-CoV-2 vaccine.
References
Publications (0)
Data not yet available
No reference posted for this study.