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.
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.
Taiwan1 site, 1 recruiting
- Recruiting
TuCheng Hospital
New Taipei City, 23652
Chia-Hsun Hsieh, PhD, 0975366137, wisdom5000@cgmh.org.tw
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 group | Role | What they receive |
|---|---|---|
| Chemotherapy | Cancer Patients underwent chemotherapy Receives: Diagnostic Test: solid organ malignancies treatment | |
| Targeted therapy | Patients underwent targeted therapy Receives: Diagnostic Test: solid organ malignancies treatment | |
| Immunotherapy | Patients underwent immunotherapy Receives: Diagnostic Test: solid organ malignancies treatment | |
| Disease-free | Cancer 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.
COVID-19 N Ab trends among different subgroups (anti-cancer therapies)
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 3 month
COVID-19 N Ab trends among different subgroups (anti-cancer therapies)
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 6 month
COVID-19 N Ab trends among different subgroups (anti-cancer therapies)
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 9 month
COVID-19 N Ab trends among different subgroups (anti-cancer therapies)
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 12 month
COVID-19 S Ab trends among different subgroups (anti-cancer therapies)
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 3 month
COVID-19 S Ab trends among different subgroups (anti-cancer therapies)
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 6 month
COVID-19 S Ab trends among different subgroups (anti-cancer therapies)
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 9 month
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)
COVID-19 N Ab trends among different baseline PhenoAge scores
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 3 month
COVID-19 N Ab trends among different baseline PhenoAge scores
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 6 month
COVID-19 N Ab trends among different baseline PhenoAge scores
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 9 month
COVID-19 N Ab trends among different baseline PhenoAge scores
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 12 month
COVID-19 S Ab trends among different baseline PhenoAge scores
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 3 month
COVID-19 S Ab trends among different baseline PhenoAge scores
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 6 month
COVID-19 S Ab trends among different baseline PhenoAge scores
COVID-19 antibodies measure after COVID-19 vaccination
Measured: 9 month
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.
- First posted20 May 2022
- Study start1 Dec 2021
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hsun Hsieh, PhD, Study director, Professor Attending Physicians
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05384509
- Acronym / sponsor ID
- 202101960B0
- Conditions
- Cancer
- Keywords
- Immunotherapy, Chemotherapy, Targeted therapy, COVID-19 vaccination, Neutralizing antibody titers, Spike protein antibody titers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | Diagnostic Test: solid organ malignancies treatmentCancer Patients underwent chemotherapy |
| Targeted therapy | – | Diagnostic Test: solid organ malignancies treatmentPatients underwent targeted therapy |
| Immunotherapy | – | Diagnostic Test: solid organ malignancies treatmentPatients underwent immunotherapy |
| Disease-free | – | Diagnostic Test: solid organ malignancies treatmentCancer patients have been disease-free for ≥ 6 months group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solid organ malignancies treatmentMajor 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. | Diagnostic test | Chemotherapy, Disease-free, Immunotherapy, Targeted therapy |
Primary outcome
COVID-19 N Ab trends among different subgroups (anti-cancer therapies)
Time frame: 3 month
COVID-19 antibodies measure after COVID-19 vaccination
COVID-19 N Ab trends among different subgroups (anti-cancer therapies)
Time frame: 6 month
COVID-19 antibodies measure after COVID-19 vaccination
COVID-19 N Ab trends among different subgroups (anti-cancer therapies)
Time frame: 9 month
COVID-19 antibodies measure after COVID-19 vaccination
COVID-19 N Ab trends among different subgroups (anti-cancer therapies)
Time frame: 12 month
COVID-19 antibodies measure after COVID-19 vaccination
COVID-19 S Ab trends among different subgroups (anti-cancer therapies)
Time frame: 3 month
COVID-19 antibodies measure after COVID-19 vaccination
COVID-19 S Ab trends among different subgroups (anti-cancer therapies)
Time frame: 6 month
COVID-19 antibodies measure after COVID-19 vaccination
COVID-19 S Ab trends among different subgroups (anti-cancer therapies)
Time frame: 9 month
COVID-19 antibodies measure after COVID-19 vaccination
COVID-19 S Ab trends among different subgroups (anti-cancer therapies)
Time frame: 12 month
COVID-19 antibodies measure after COVID-19 vaccination
8 secondary outcomes
COVID-19 N Ab trends among different baseline PhenoAge scores
Time frame: 3 month
COVID-19 N Ab trends among different baseline PhenoAge scores
Time frame: 6 month
COVID-19 N Ab trends among different baseline PhenoAge scores
Time frame: 9 month
COVID-19 N Ab trends among different baseline PhenoAge scores
Time frame: 12 month
COVID-19 S Ab trends among different baseline PhenoAge scores
Time frame: 3 month
COVID-19 S Ab trends among different baseline PhenoAge scores
Time frame: 6 month
COVID-19 S Ab trends among different baseline PhenoAge scores
Time frame: 9 month
COVID-19 S Ab trends among different baseline PhenoAge scores
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chia-Hsun Hsieh, PhD study director
Professor Attending Physicians
1 site in 1 country: see every site and its status.
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.