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

NCT05384509 | Recruiting

• 1 other identifier: 202101960B0
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Immunotherapy; Chemotherapy; Targeted therapy; COVID-19 vaccination; Neutralizing antibody titers; Spike protein antibody titers

Outcome Measures

Primary Outcomes (8)

• COVID-19 N Ab trends among different subgroups (anti-cancer therapies)

  COVID-19 antibodies measure after COVID-19 vaccination

  3 month

• COVID-19 N Ab trends among different subgroups (anti-cancer therapies)

  COVID-19 antibodies measure after COVID-19 vaccination

  6 month

• COVID-19 N Ab trends among different subgroups (anti-cancer therapies)

  COVID-19 antibodies measure after COVID-19 vaccination

  9 month

• COVID-19 N Ab trends among different subgroups (anti-cancer therapies)

  COVID-19 antibodies measure after COVID-19 vaccination

  12 month

• COVID-19 S Ab trends among different subgroups (anti-cancer therapies)

  COVID-19 antibodies measure after COVID-19 vaccination

  3 month

• COVID-19 S Ab trends among different subgroups (anti-cancer therapies)

  COVID-19 antibodies measure after COVID-19 vaccination

  6 month

• COVID-19 S Ab trends among different subgroups (anti-cancer therapies)

  COVID-19 antibodies measure after COVID-19 vaccination

  9 month

• COVID-19 S Ab trends among different subgroups (anti-cancer therapies)

  COVID-19 antibodies measure after COVID-19 vaccination

  12 month

Secondary Outcomes (8)

• COVID-19 N Ab trends among different baseline PhenoAge scores

  3 month

• COVID-19 N Ab trends among different baseline PhenoAge scores

  6 month

• COVID-19 N Ab trends among different baseline PhenoAge scores

  9 month

• COVID-19 N Ab trends among different baseline PhenoAge scores

  12 month

• COVID-19 S Ab trends among different baseline PhenoAge scores

  3 month

Study Arms (4)

Chemotherapy

Cancer Patients underwent chemotherapy

Diagnostic Test: solid organ malignancies treatment

Targeted therapy

Patients underwent targeted therapy

Diagnostic Test: solid organ malignancies treatment

Immunotherapy

Patients underwent immunotherapy

Diagnostic Test: solid organ malignancies treatment

Disease-free

Cancer patients have been disease-free for ≥ 6 months group

Diagnostic Test: solid organ malignancies treatment

Interventions

solid organ malignancies treatment DIAGNOSTIC_TEST

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.

Chemotherapy; Disease-free; Immunotherapy; Targeted therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

At TuCheng Hospital and Linkou Chang Gung Memorial Hospital, Cancer Patients underwent chemotherapy were enrolled as the first group (1). Patients underwent targeted therapy were enrolled as the second group (2). Cancer Patients underwent immunotherapy were enrolled as the third group (3). Cancer patients have been disease-free for ≥ 6 months group were enrolled as the fourth group (4).

You may qualify if:

• adults \>20 years old;
• 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)
• cancer patients who were full vaccinated with any brand of vaccines or cancer patients who were unvaccinated agree to complete full vaccination later.
• patients who agreed with the content of informed consent of the study protocol.

You may not qualify if:

• Patients who refused the protocol of N-antibody test and Out-Patient Departments follow-up.
• The investigators suggest to withdraw.
• Patient asked to withdraw from the trial at any timepoints.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

TuCheng Hospital

New Taipei City, 23652, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Neoplasms

Study Officials

• Chia-Hsun Hsieh, PhD

  Professor Attending Physicians

  STUDY DIRECTOR

Central Study Contacts

Chia-Hsun Hsieh, PhD

CONTACT

0975366137; wisdom5000@cgmh.org.tw

Jeng How Yang, PhD

CONTACT

0975366159; woody1005@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 20, 2022
• Study Start: December 1, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-10

Locations

TW (1)