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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04894682
Other study ID # KY-Q-2021-087-01
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


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
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