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Changes of the anti-epidemic policy
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated Case | Pulmonary nodules/lung cancer patients who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) |
| |
| Vaccinated Healthy Control | Healthy people who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) |
| |
| Unvaccinated Case | Pulmonary nodules/lung cancer patients who are not vaccinated against the SARS-CoV-2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine inoculation against SARS-CoV-2 | Biological | Inoculation with any type of approved vaccines according to the standard or recommended dose |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All participants in the vaccinated case and unvaccinated case group are/were diagnosed with pulmonary nodules by CT scan or lung cancer by pathological examination, and are enrolled by invitation from the patient registry database(established and maintained by Department of Thoracic Surgery, Guangdong Provincial People's Hospital). All participants in the healthy control group are free of any malignant diseases, including indeterminate tumors in any body part, and are enrolled by randomly invitation from the public.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
Raw anonymized data are available from corresponding investigator upon reasonable request.
Immediately after the completion of study/publication of results, and will be available for 2 years.
For pooled study or meta-analysis only.
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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 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D003074 | Solitary Pulmonary Nodule |
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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