Monitoring COVID-19 antibody levels in cancer patients undergoing treatment
(COVID-19) Longitudinal Neutralizing Antibody Titers in Cancer Patients Receiving Different Anti-caner Therapies: a Retrospective Cost Research and Prospective Longitudinal Monitoring Study
This study is testing how well COVID-19 vaccines work in cancer patients getting different treatments to see if their antibody levels are strong enough to protect them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT05384509 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the levels of neutralizing antibodies against COVID-19 in cancer patients receiving various anti-cancer therapies, including chemotherapy, targeted therapy, and immunotherapy. It involves enrolling patients with solid tumors and hematologic malignancies, as well as healthy volunteers, to evaluate the kinetics of these antibodies post-vaccination. The study seeks to provide critical data on the safety and efficacy of COVID-19 vaccinations in this vulnerable population, which has been largely excluded from previous vaccine trials. By analyzing a large dataset, the researchers hope to inform treatment decisions and risk assessments for cancer patients during the ongoing pandemic.
Who should consider this trial
Good fit: Ideal candidates include adults over 20 years old who are currently undergoing active anti-cancer therapy or have been disease-free for at least six months.
Not a fit: Patients who are not undergoing any form of anti-cancer therapy or those who refuse to participate in the antibody testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide essential insights into the immune response to COVID-19 vaccination in cancer patients, potentially guiding safer treatment protocols.
How similar studies have performed: While there is limited data on similar studies, the approach of monitoring COVID-19 antibody responses in cancer patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. adults \>20 years old; 2. cancer patients under active anti-cancer therapy, including chemotherapy (n=80), targeted therapy (n=80) and immunotherapy (n=80); and cancer patients have been disease-free for ≥ 6 months (n=80) 3. cancer patients who were full vaccinated with any brand of vaccines or cancer patients who were unvaccinated agree to complete full vaccination later. 4. patients who agreed with the content of informed consent of the study protocol. Exclusion Criteria: 1. Patients who refused the protocol of N-antibody test and Out-Patient Departments follow-up. 2. The investigators suggest to withdraw. 3. Patient asked to withdraw from the trial at any timepoints.
Where this trial is running
New Taipei City
- TuCheng Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chia-Hsun Hsieh, PhD
- Email: wisdom5000@cgmh.org.tw
- Phone: 0975366137
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.