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

NCT ID: NCT04894682

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-04

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaccinated Case

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

Vaccine inoculation against SARS-CoV-2

Intervention Type BIOLOGICAL

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)

Vaccine inoculation against SARS-CoV-2

Intervention Type BIOLOGICAL

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

No interventions assigned to this group

Interventions

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Vaccine inoculation against SARS-CoV-2

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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GuiBin Qiao

Administrative Director, Department of Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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KY-Q-2021-087-01

Identifier Type: -

Identifier Source: org_study_id

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