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

Withdrawn

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

• Registration Number: NCT04894682
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

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 Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-20
• Primary Completion: 2021-08-31
• Study Completion: 2022-05-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated Healthy Control	Vaccine inoculation against SARS-CoV-2	Healthy people who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine)
Vaccinated Case	Vaccine inoculation against SARS-CoV-2	Pulmonary nodules/lung cancer patients who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine)

Primary Outcome Measures

Name	Time	Method
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
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 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

Name	Time	Method
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)

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China