COVID-19 Pneumonia, Lung Cancer, Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary, SARS-CoV-2 Acute Respiratory Disease, Vaccine Adverse Reaction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALVaccine inoculation against SARS-CoV-2
Inoculation with any type of approved vaccines according to the standard or recommended dose
Sponsors
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence rate of vaccination-related adverse effects | Vaccination-related adverse effects are monitored from the time of inoculation, up to 1 month after each inoculation | Occurence rate of vaccination-related adverse effects in case group and healthy control group |
| Time to progression of pulmonary nodules | The date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan, up to 12 months | Time calculated from the date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan |
| Time to recurrence of lung cancer | The date of vaccine inoculation to the date of reported recurrence of lung cancer by pathological examination, up to 12 months | Time calculated from the date of vaccine inoculation to the date of reported recurrence of lung cancer confirmed by pathological examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of vaccination-related adverse effects | Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation | The period of time calculated from the occurrence of vaccination-related adverse effects to the time of remission |
| Severity of vaccination-related adverse effects | Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation | 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) |
Countries
China
Outcome results
None listed