Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor
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.
Full Title of Study: “Safety and Long-term Effects of COVID-19 Vaccines in Patients With Lung Cancer or Indeterminate Pulmonary Nodule–A Real World Study”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: August 31, 2021
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
- Biological: Vaccine inoculation against SARS-CoV-2
- Inoculation with any type of approved vaccines according to the standard or recommended dose
Arms, Groups and Cohorts
- 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
Clinical Trial Outcome Measures
Primary Measures
- Occurence rate of vaccination-related adverse effects
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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 Measures
- Duration of vaccination-related adverse effects
- Time Frame: 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
- Time Frame: 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)
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 85 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Guangdong Provincial People’s Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: GuiBin Qiao, Administrative Director, Department of Thoracic Surgery – Guangdong Provincial People’s Hospital
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