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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Withdrawn

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

Treatments: Biological: Vaccine inoculation against SARS-CoV-2

Study type: Observational

Funder types: Other

Identifiers

NCT04894682

KY-Q-2021-087-01

Details and patient eligibility

About

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 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 3 patient groups

Vaccinated Case

Description:

Pulmonary nodules/lung cancer patients who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine)

Treatment:

Biological: Vaccine inoculation against SARS-CoV-2

Vaccinated Healthy Control

Description:

Healthy people who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine)

Treatment:

Biological: Vaccine inoculation against SARS-CoV-2

Unvaccinated Case

Description:

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