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

Study Overview
=================
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.

Official Title
-----------------
Safety and Long-term Effects of COVID-19 Vaccines in Patients With Lung Cancer or Indeterminate Pulmonary Nodule--A Real World Study

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

Intervention / Treatment
-----------------
* Biological: Vaccine inoculation against SARS-CoV-2


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccinated Case<br>Pulmonary nodules/lung cancer patients who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) | Biological: Vaccine inoculation against SARS-CoV-2<br>* Inoculation with any type of approved vaccines according to the standard or recommended dose<br>|
| Vaccinated Healthy Control<br>Healthy people who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) | Biological: Vaccine inoculation against SARS-CoV-2<br>* Inoculation with any type of approved vaccines according to the standard or recommended dose<br>|
| Unvaccinated Case<br>Pulmonary nodules/lung cancer patients who are not vaccinated against the SARS-CoV-2 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence rate of vaccination-related adverse effects | Occurence rate of vaccination-related adverse effects in case group and healthy control group | 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 | 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 | The date of vaccine inoculation to the date of reported recurrence of lung cancer by pathological examination, up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of vaccination-related adverse effects | The period of time calculated from the occurrence of vaccination-related adverse effects to the time of remission | 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) | Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation |