Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor (CoVac-Lung)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Vaccine Adverse Reaction; Lung Cancer; COVID-19 Pneumonia; SARS-CoV-2 Acute Respiratory Disease; Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple
• Intervention / Treatment: Biological: Vaccine inoculation against SARS-CoV-2

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 Type: Observational

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; COVID-19; Lung Neoplasms; Multiple Pulmonary Nodules; Respiration Disorders; Respiratory Tract Diseases; Solitary Pulmonary Nodule
• Other Study ID Numbers: KY-Q-2021-087-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw anonymized data are available from corresponding investigator upon reasonable request.
• IPD Sharing Time Frame: Immediately after the completion of study/publication of results, and will be available for 2 years.
• IPD Sharing Access Criteria: For pooled study or meta-analysis only.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No