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

Lung Cancer Clinical Trial

— CoVac-Lung  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04894682
• Other study ID #: KY-Q-2021-087-01
• Status: Withdrawn
• Start date: May 4, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2023
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Lung Cancer
• Lung Neoplasms
• Multiple Pulmonary Nodules
• Pulmonary Nodule, Multiple
• Pulmonary Nodule, Solitary
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease
• Solitary Pulmonary Nodule
• Vaccine Adverse Reaction

Intervention

Biological:
• Vaccine inoculation against SARS-CoV-2
Inoculation with any type of approved vaccines according to the standard or recommended dose

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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