Lung CancerCoVac-LungNCT04894682
Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor
An observational study of Lung Cancer and Pulmonary Nodule, Solitary, run by Guangdong Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
- What is being tested?
- Vaccine inoculation against SARS-CoV-2
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who have been vaccinated against the SARS-CoV-2
- Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who are not vaccinated against the SARS-CoV-2
- Healthy people who have been vaccinated against the SARS-CoV-2
Who cannot join
- Multiple malignancy in other parts of body;
- Infected with SARS-CoV-2 virus currently or in the past;
- Refuse to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Long-term Effects of COVID-19 Vaccines in Patients With Lung Cancer or Indeterminate Pulmonary Nodule--A Real World Study
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.
Read the 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.
- Conditions
- Lung Cancer, Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple, COVID-19 Pneumonia, Vaccine Adverse Reaction, SARS-CoV-2 Acute Respiratory Disease
- Being tested
- Vaccine inoculation against SARS-CoV-2
- Medical subject headings
- Lung Neoplasms, Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine inoculation against SARS-CoV-2Biological
Inoculation with any type of approved vaccines according to the standard or recommended dose
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated Case | Pulmonary nodules/lung cancer patients who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) Receives: Biological: Vaccine inoculation against SARS-CoV-2 | |
| Vaccinated Healthy Control | Healthy people who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) Receives: Biological: Vaccine inoculation against SARS-CoV-2 | |
| Unvaccinated Case | Pulmonary nodules/lung cancer patients who are not vaccinated against the SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence rate of vaccination-related adverse effects
Occurence rate of vaccination-related adverse effects in case group and healthy control group
Measured: Vaccination-related adverse effects are monitored from the time of inoculation, up to 1 month after each inoculation
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
Measured: The date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan, up to 12 months
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
Measured: The date of vaccine inoculation to the date of reported recurrence of lung cancer by pathological examination, up to 12 months
Secondary outcomes (2)
Duration of vaccination-related adverse effects
The period of time calculated from the occurrence of vaccination-related adverse effects to the time of remission
Measured: Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation
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)
Measured: Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start4 May 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion31 May 2022 (estimated)
Why it stopped: Changes of the anti-epidemic policy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GuiBin Qiao, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894682
- Sponsor's protocol ID
- KY-Q-2021-087-01
- Acronym
- CoVac-Lung
- Status last verified
- Mar 2023
- First submitted
- 6 May 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw anonymized data are available from corresponding investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Long-term Effects of COVID-19 Vaccines in Patients With Lung Cancer or Indeterminate Pulmonary Nodule--A Real World Study
- ClinicalTrials.gov ID
- NCT04894682
- Acronym / sponsor ID
- CoVac-Lung / KY-Q-2021-087-01
- Conditions
- Lung Cancer, Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple, COVID-19 Pneumonia, Vaccine Adverse Reaction, SARS-CoV-2 Acute Respiratory Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Changes of the anti-epidemic policy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccinated Case | – | Biological: Vaccine inoculation against SARS-CoV-2Pulmonary nodules/lung cancer patients who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) |
| Vaccinated Healthy Control | – | Biological: Vaccine inoculation against SARS-CoV-2Healthy people who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine) |
| Unvaccinated Case | – | –Pulmonary nodules/lung cancer patients who are not vaccinated against the SARS-CoV-2 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who have been vaccinated against the SARS-CoV-2
- Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who are not vaccinated against the SARS-CoV-2
- Healthy people who have been vaccinated against the SARS-CoV-2
Key exclusion criteria (3 listed)
- Multiple malignancy in other parts of body;
- Infected with SARS-CoV-2 virus currently or in the past;
- Refuse to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine inoculation against SARS-CoV-2Inoculation with any type of approved vaccines according to the standard or recommended dose | Biological | Vaccinated Case, Vaccinated Healthy Control |
Primary outcome
Occurence rate of vaccination-related adverse effects
Time frame: Vaccination-related adverse effects are monitored from the time of inoculation, up to 1 month after each inoculation
Occurence rate of vaccination-related adverse effects in case group and healthy control group
Time to progression of pulmonary nodules
Time frame: The date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan, up to 12 months
Time calculated from the date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan
Time to recurrence of lung cancer
Time frame: The date of vaccine inoculation to the date of reported recurrence of lung cancer by pathological examination, up to 12 months
Time calculated from the date of vaccine inoculation to the date of reported recurrence of lung cancer confirmed by pathological examination
2 secondary outcomes
Duration of vaccination-related adverse effects
Time frame: Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation
Severity of vaccination-related adverse effects
Time frame: Vaccination-related adverse events are monitored from the time of inoculation, up to 1 month after each inoculation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: Yes. Raw anonymized data are available from corresponding investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Pulmonary Nodule, Solitary, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence rate of vaccination-related adverse effects (time frame: Vaccination-related adverse effects are monitored from the time of inoculation, up to 1 month after each inoculation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.