CoVac-Lung: Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Vaccinated Case 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
Inoculation with any type of approved vaccines according to the standard or recommended dose
|
| Vaccinated Healthy Control Healthy people who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) |
Biological: Vaccine inoculation against SARS-CoV-2
Inoculation with any type of approved vaccines according to the standard or recommended dose
|
| Unvaccinated Case Pulmonary nodules/lung cancer patients who are not vaccinated against the SARS-CoV-2 |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
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:
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Multiple malignancy in other parts of body;
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Infected with SARS-CoV-2 virus currently or in the past;
-
Refuse to participate in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- Guangdong Provincial People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY-Q-2021-087-01