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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05384509

Collaborator

(none)

320

Enrollment

Location

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with cancer are considered vulnerable to SARS-CoV-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 SARS- CoV-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- SARS-CoV-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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Diagnostic Test: solid organ malignancies treatment

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 (SARS-CoV-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 TuCheng Hospital has established a special infectious pneumonia ward in May 2021 to treat patients infected with symptomatic SARS-CoV-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 (SARS-CoV-2) has spread globally over the past year, infecting an immunologically naive population and causing significant morbidity and mortality. Immunity to SARS-CoV-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 SARS-CoV-2, which causes severe respiratory illness or death. Serum neutralizing antibodies rapidly appear after SARS-CoV-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 SARS-CoV-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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

320 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Chemotherapy Cancer Patients underwent chemotherapy	Diagnostic Test: 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.
Targeted therapy Patients underwent targeted therapy	Diagnostic Test: 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.
Immunotherapy Patients underwent immunotherapy	Diagnostic Test: 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.
Disease-free Cancer patients have been disease-free for ≥ 6 months group	Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

SARS COVID N Ab trends among different subgroups (anti-cancer therapies) [3 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID N Ab trends among different subgroups (anti-cancer therapies) [6 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID N Ab trends among different subgroups (anti-cancer therapies) [9 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID N Ab trends among different subgroups (anti-cancer therapies) [12 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID S Ab trends among different subgroups (anti-cancer therapies) [3 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID S Ab trends among different subgroups (anti-cancer therapies) [6 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID S Ab trends among different subgroups (anti-cancer therapies) [9 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID S Ab trends among different subgroups (anti-cancer therapies) [12 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination

Secondary Outcome Measures

SARS COVID N Ab trends among different baseline PhenoAge scores [3 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID N Ab trends among different baseline PhenoAge scores [6 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID N Ab trends among different baseline PhenoAge scores [9 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID N Ab trends among different baseline PhenoAge scores [12 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID S Ab trends among different baseline PhenoAge scores [3 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID S Ab trends among different baseline PhenoAge scores [6 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID S Ab trends among different baseline PhenoAge scores [9 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination
SARS COVID S Ab trends among different baseline PhenoAge scores [12 month]
anti- SARS-CoV-2 antibodies measure after COVID-19 vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 (AZ, BNT, Moderna or others, as stratification factors in the analysis) 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.