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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