Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor

NCT04894682 | Withdrawn

• 1 other identifier: KY-Q-2021-087-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple; COVID-19 Pneumonia; Vaccine Adverse Reaction; SARS-CoV-2 Acute Respiratory Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Duration of vaccination-related adverse effects

  Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation

• Severity of vaccination-related adverse effects

  Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation

Study Arms (3)

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

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

Unvaccinated Case

Pulmonary nodules/lung cancer patients who are not vaccinated against the SARS-CoV-2

Interventions

Vaccine inoculation against SARS-CoV-2 BIOLOGICAL

Inoculation with any type of approved vaccines according to the standard or recommended dose

Vaccinated Case; Vaccinated Healthy Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Multiple malignancy in other parts of body;
• Infected with SARS-CoV-2 virus currently or in the past;
• Refuse to participate in this study.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrative Director, Department of Thoracic Surgery

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 20, 2021
• Study Start: May 4, 2021
• Primary Completion: August 31, 2021
• Study Completion: May 31, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately after the completion of study/publication of results, and will be available for 2 years.
• Access Criteria: For pooled study or meta-analysis only.

Locations

CN (1)