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Clinical Trials in Taiwan / NCT05384509
Recruiting Observational

(COVID-19) Longitudinal Neutralizing Antibody Titers in Cancer Patients Receiving Different Anti-caner Therapies

NCT05384509 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Chang Gung Memorial Hospital
Phase
Observational
Started
2021-12-01
Last updated
2025-02-27

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

solid organ malignancies treatment

solid organ malignancies treatment: Major inclusion criteria for this cohort of the study included: (1) age above 20 years; (2) presence of solid organ malignancies treated with immunotherapy, chemotherapy, Target therapy irrespective of the treatment phase; and (3) eligibility for vaccination.

Study summary

Patients with cancer are considered vulnerable to severe acute respiratory syndrome coronavirus 2 infection and have been prioritized in the vaccination process in several countries, including Taiwan. In addition, international oncological societies favored COVID-19 vaccination for cancer patients on the basis of risk and benefits evaluation of all available data. However, patients with cancer were excluded from severe acute respiratory syndrome coronavirus 2 vaccines registrational trials and the investigators lack data regarding the safety and efficacy of vaccination in this population. Under this perspective, the investigators undertook a large prospective study enrolling patients with solid cancers, hematologic malignancies as well as healthy volunteers for the kinetics of anti-severe acute respiratory syndrome coronavirus 2 antibodies after COVID-19 vaccination on different anticancer therapy. Major inclusion criteria for this cohort of the study included: (1) age above 20 years; (2) presence of solid organ malignancies treated with immunotherapy, chemotherapy, Targeted therapy irrespective of the treatment phase; and (3) eligibility for vaccination.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • COVID-19 N Ab trends among different subgroups (anti-cancer therapies) — 3 month
    COVID-19 antibodies measure after COVID-19 vaccination
  • COVID-19 N Ab trends among different subgroups (anti-cancer therapies) — 6 month
    COVID-19 antibodies measure after COVID-19 vaccination
  • COVID-19 N Ab trends among different subgroups (anti-cancer therapies) — 9 month
    COVID-19 antibodies measure after COVID-19 vaccination
  • COVID-19 N Ab trends among different subgroups (anti-cancer therapies) — 12 month
    COVID-19 antibodies measure after COVID-19 vaccination
  • COVID-19 S Ab trends among different subgroups (anti-cancer therapies) — 3 month
    COVID-19 antibodies measure after COVID-19 vaccination
  • COVID-19 S Ab trends among different subgroups (anti-cancer therapies) — 6 month
    COVID-19 antibodies measure after COVID-19 vaccination
  • COVID-19 S Ab trends among different subgroups (anti-cancer therapies) — 9 month
    COVID-19 antibodies measure after COVID-19 vaccination
  • COVID-19 S Ab trends among different subgroups (anti-cancer therapies) — 12 month
    COVID-19 antibodies measure after COVID-19 vaccination

Trial sites (1)

FacilityCityRegionStatus
TuCheng Hospital New Taipei City Taiwan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05384509 on ClinicalTrials.gov ↗ ← All trials in Taiwan