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CancerNCT05384509

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

An observational study of Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Cancer
What is being tested?
solid organ malignancies treatment
Type of treatment
Vaccines
How many people
320 participants
Where
1 siteTaiwan
Study dates
1 Dec 2021to 28 Feb 2025
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chia-Hsun Hsieh, PhD contact

0975366137

wisdom5000@cgmh.org.tw

Jeng How Yang, PhD contact

0975366159

woody1005@cgmh.org.tw

Taiwan1 site, 1 recruiting
  • TuCheng Hospital

    New Taipei City, 23652

    Chia-Hsun Hsieh, PhD, 0975366137, wisdom5000@cgmh.org.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: (COVID-19) Longitudinal Neutralizing Antibody Titers in Cancer Patients Receiving Different Anti-caner Therapies: a Retrospective Cost Research and Prospective Longitudinal Monitoring Study

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.

Read the detailed description

Patients with cancer receiving systemic anti-cancer treatments have been generally assumed by many to be at a higher risk from the disease than their counterparts are who are not receiving anticancer treatment. However, their risk of morbidity and mortality from COVID-19 as a consequence of severe acute respiratory syndrome coronavirus 2 infection is not uniform across the world. The evidence to support this claim is scarce and limited to retrospective series arising from China, the epicenter of the COVID-19 pandemic, and involving small numbers of patients. However, despite these severe limitations, the promulgation of this hypothesis has led to widespread global changes to patterns of prescribing chemotherapy and anticancer treatment. In a global health emergency, oncologists, must secure evidence from a large datasets, which can then inform their risk-benefit analyses for individual patients in terms of the use of anticancer treatments. On March 18, 2020, the investigators launched the UK Coronavirus Cancer Monitoring Project (UKCCMP), with widespread support across our national cancer network. 8 Within 5 weeks, the UKCCMP had generated the largest prospective database of COVID-19 in patients with cancer that had been generated to date. the investigators aimed to describe the clinical and demographic characteristics and COVID-19 outcomes in this cohort of patients with cancer and symptomatic COVID-19, and attempted to assess how the presence of cancer and the receipt of cytotoxic chemotherapy and other anticancer treatments affects the COVID-19 disease phenotype.

New Taipei City Municipal Hospital has established a special infectious pneumonia ward in May 2021 to treat patients infected with symptomatic severe acute respiratory syndrome coronavirus 2 patients. During the period, 97 patients were admitted and treated with 10 infection-related deaths. In light of the current timing of the pandemic, most published serological studies are predominantly cross-sectional, or at most, include a longitudinal follow-up of few months. Severe acute respiratory syndrome coronavirus 2 has spread globally over the past year, infecting an immunologically naive population and causing significant morbidity and mortality. Immunity to severe acute respiratory syndrome coronavirus 2 induced either through natural infection or vaccination has been shown to afford a degree of protection against reinfection and/or reduce the risk of clinically significant outcomes. Seropositive recovered subjects have been estimated to have 89% protection from reinfection, and vaccine efficacies from 50 to 95% have been reported. However, the duration of protective immunity is presently unclear, primary immune responses are inevitably waning, and there is ongoing transmission of increasingly concerning viral variants that may escape control by both vaccine-induced and convalescent immune responses.

Age is considered one of the most crucial covariates that affect phenotypes. However, aging rate may vary among different populations due to genetic variation or miscellaneous environmental exposures. Chronological age is not a perfect proxy for the true biological aging status of the body. A new biological aging measure, phenotypic age (PhenoAge), has been shown to capture morbidity and mortality risk in the general US population and diverse subpopulations. However, how the phenotypic age affect host immunity is not well investigated.

There are currently no effective therapies for severe acute respiratory syndrome coronavirus 2, which causes severe respiratory illness or death. Serum neutralizing antibodies rapidly appear after severe acute respiratory syndrome coronavirus 2 infection and vaccination. However, little was known about the change of protective antibody titers both to nature infection and post vaccination. And there is ongoing transmission of increasingly concerning viral variants that may escape control by both vaccine-induced and convalescent immune responses. Defining the antibody response to severe acute respiratory syndrome coronavirus 2 in patients with cancer receiving anti-cancer therapy, (including chemotherapy, targeted therapy and immunotherapy) will be essential for understanding infection progression, long-term immunity, vaccine efficacy and how phenotypic age affect associated antibodies.

Conditions
Cancer
Being tested
solid organ malignancies treatment
Keywords
Immunotherapy, Chemotherapy, Targeted therapy, COVID-19 vaccination, Neutralizing antibody titers, Spike protein antibody titers
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • solid organ malignancies treatmentDiagnostic 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.

Study groups in NCT05384509
Study groupRoleWhat they receive
ChemotherapyCancer Patients underwent chemotherapy
Receives: Diagnostic Test: solid organ malignancies treatment
Targeted therapyPatients underwent targeted therapy
Receives: Diagnostic Test: solid organ malignancies treatment
ImmunotherapyPatients underwent immunotherapy
Receives: Diagnostic Test: solid organ malignancies treatment
Disease-freeCancer patients have been disease-free for ≥ 6 months group
Receives: Diagnostic Test: solid organ malignancies treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 3 month

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

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 6 month

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

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 9 month

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

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 12 month

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

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 3 month

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

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 6 month

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

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 9 month

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

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 12 month

Secondary outcomes (8)
  1. COVID-19 N Ab trends among different baseline PhenoAge scores

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 3 month

  2. COVID-19 N Ab trends among different baseline PhenoAge scores

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 6 month

  3. COVID-19 N Ab trends among different baseline PhenoAge scores

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 9 month

  4. COVID-19 N Ab trends among different baseline PhenoAge scores

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 12 month

  5. COVID-19 S Ab trends among different baseline PhenoAge scores

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 3 month

  6. COVID-19 S Ab trends among different baseline PhenoAge scores

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 6 month

  7. COVID-19 S Ab trends among different baseline PhenoAge scores

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 9 month

  8. COVID-19 S Ab trends among different baseline PhenoAge scores

    COVID-19 antibodies measure after COVID-19 vaccination

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start1 Dec 2021
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
320 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05384509
Sponsor's protocol ID
202101960B0
Status last verified
Oct 2024
First submitted
4 May 2022
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chia-Hsun Hsieh, PhD (0975366137, wisdom5000@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COVID-19 N Ab trends among different subgroups (anti-cancer therapies) (time frame: 3 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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