Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor

Guangdong Provincial People's Hospital

Overview

The objective of this study is to assess the inoculation-related symptoms and long-term effects of COVID-19 vaccines in patients with lung cancer or pulmonary nodules in a real-world setting. The investigators aim to provide high-quality evidence for the COVID-19 vaccines in cancer/pre-cancer patients, and to address their concern about the safety profile of the newly developed vaccines.

This study will enroll lung cancer/pulmonary nodule patients or healthy people who had undergone standard vaccination procedures against SARS-CoV-2/COVID-19. This observatory study will apply an electronic questionnaire to collect general information and post-vaccination symptoms or adverse events of vaccinated pulmonary nodules/lung cancer patients and healthy control. The researchers will further analyze whether the vaccine will promote the progression of primary tumors/pulmonary nodules through long-term follow-up. The investigators aim to assess the adverse events and long-term impact of COVID-19 vaccines in patients with lung cancer or pulmonary nodules in a real-world setting, to provide high-quality evidence for the COVID-19 vaccines in cancer/pre-cancer patients, and to address their concern about the safety profile of the newly developed vaccines.

Study Type

OBSERVATIONAL

Conditions

Lung Cancer Pulmonary Nodule, Solitary Pulmonary Nodule, Multiple COVID-19 Pneumonia Vaccine Adverse Reaction SARS-CoV-2 Acute Respiratory Disease

Interventions

Vaccine inoculation against SARS-CoV-2BIOLOGICAL

Inoculation with any type of approved vaccines according to the standard or recommended dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who have been vaccinated against the SARS-CoV-2 2. Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who are not vaccinated against the SARS-CoV-2 3. Healthy people who have been vaccinated against the SARS-CoV-2 Exclusion Criteria: 1. Multiple malignancy in other parts of body; 2. Infected with SARS-CoV-2 virus currently or in the past; 3. Refuse to participate in this study.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Occurence rate of vaccination-related adverse effects

Occurence rate of vaccination-related adverse effects in case group and healthy control group

Time frame: Vaccination-related adverse effects are monitored from the time of inoculation, up to 1 month after each inoculation

Time to progression of pulmonary nodules

Time calculated from the date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan

Time frame: The date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan, up to 12 months

Time to recurrence of lung cancer

Time calculated from the date of vaccine inoculation to the date of reported recurrence of lung cancer confirmed by pathological examination

Time frame: The date of vaccine inoculation to the date of reported recurrence of lung cancer by pathological examination, up to 12 months

Secondary Outcomes

Duration of vaccination-related adverse effects

The period of time calculated from the occurrence of vaccination-related adverse effects to the time of remission

Time frame: Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation

Severity of vaccination-related adverse effects

The severity of vaccination-related adverse effects is defined as three grades: Grade 1 (self-remission without any intervention); Grade 2 (Remission only after medical intervention/s); Grade 3 (Adverse event-related Hospitalization)

Time frame: Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation

Data from ClinicalTrials.gov

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