Assessing COVID-19 vaccine effectiveness in cancer patients
Multicenter, Observational Study of Anti-Sars-Cov2 Vaccine Efficacy in Patients With Malignant Pathologies Treated in the University Hospitals of AP-HP. Nord
Assistance Publique - Hôpitaux de Paris · NCT04776005
This study is testing how well COVID-19 vaccines work for cancer patients who are getting treatment to see if their type of cancer or treatment affects their response to the vaccine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | chemotherapy, Immunotherapy, radiation |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT04776005 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and immunogenicity of COVID-19 vaccines in patients with malignant diseases, including solid tumors and hematologic malignancies, who are currently undergoing treatment. Conducted at Saint Louis Hospital and Bichat Hospital, the study collects clinical and biological data during routine follow-ups to understand how various factors, such as type of cancer and treatment, affect vaccine response. Participants will receive standard care while their antibody levels and potential adverse effects from the vaccine will be monitored over a year.
Who should consider this trial
Good fit: Ideal candidates include patients with solid or hematological tumors who are actively receiving treatment at the participating hospitals.
Not a fit: Patients with contraindications to SARS-CoV-2 vaccination will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into how COVID-19 vaccines work in cancer patients, potentially leading to improved vaccination strategies for this vulnerable population.
How similar studies have performed: While there is limited data on vaccine efficacy in cancer patients, this study aims to fill a significant knowledge gap, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with malignant disease undergoing treatment at Saint Louis Hospital or Bichat Hospital (for chest cancer) * with chemotherapy * with chemotherapy + Immunotherapy * with immunotherapy * with targeted therapies * with radiotherapy * in the event of radiation pneumonitis after radiotherapy for lung cancers * after pneumonectomy for lung cancer * Patient informed and having expressed their non-opposition to participating in this research Exclusion Criteria: * Patient with a contraindication to Sars-Cov2 vaccination
Where this trial is running
Paris and 1 other locations
- Saint-Louis Hospital, AP-HP — Paris, France (RECRUITING)
- Bichat Hospital, AP-HP — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Luis TEIXEIRA, MD, PhD — Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976
- Study coordinator: Luis TEIXEIRA, MD, PhD
- Email: luis.teixeira@aphp.fr
- Phone: +33 142499613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumor, Hematologic Malignancy, Thoracic Cancer, Cancer, Treatment-Related, Vaccine Response Impaired, Malignant pathology, Hematologic malignancy, COVID-19