Clinical trial NCT04894682: Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor
Official title: Safety and Long-term Effects of COVID-19 Vaccines in Patients With Lung Cancer or Indeterminate Pulmonary Nodule--A Real World Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
COVID-19 Pneumonia
Vaccine Adverse Reaction
SARS-CoV-2 Acute Respiratory Disease
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants in the vaccinated case and unvaccinated case group are/were diagnosed with pulmonary nodules by CT scan or lung cancer by pathological examination, and are enrolled by invitation from the patient registry database(established and maintained by Department of Thoracic Surgery, Guangdong Provincial People's Hospital). All participants in the healthy control group are free of any malignant diseases, including indeterminate tumors in any body part, and are enrolled by randomly invitation from the public.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurence rate of vaccination-related adverse effects
timeFrame: Vaccination-related adverse effects are monitored from the time of inoculation, up to 1 month after each inoculation
measure: Time to progression of pulmonary nodules
timeFrame: The date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan, up to 12 months
measure: Time to recurrence of lung cancer
timeFrame: The date of vaccine inoculation to the date of reported recurrence of lung cancer by pathological examination, up to 12 months
Secondary outcomes:
measure: Duration of vaccination-related adverse effects
timeFrame: Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation
measure: Severity of vaccination-related adverse effects
timeFrame: Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: