COVID-19 InfectionNCT05774171
To Explore the Protective Effect of SARS-CoV-2 Vaccination on Cancer Patients Infected With SARS-CoV-2
An observational study of COVID-19 Infection and COVID-19 Vaccine, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
For tumor patients, the virus antibody titer produced by the SARS-CoV-2 vaccine is often lower than that of normal people in a short period of time, but in the long run, it can significantly reduce the infection rate and fatality rate of the new coronavirus, and the adverse reactions are mild and there is no… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection, COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. age > 18 years old, regardless of gender; 2. patients with previous or current tumor, regardless of tumor type; 3. have a history or current infection with SARS-CoV-2; 4. The vital signs were stable, without severe pulmonary, heart, liver and other important organ dysfunction; 5. those with good compliance, agreed to participate in this clinical study, receive corresponding treatment, and signed the informed consent.
Who may be able to join
- age > 18 years old, regardless of gender;
- patients with previous or current tumor, regardless of tumor type;
- have a history or current infection with SARS-CoV-2;
- The vital signs were stable, without severe pulmonary, heart, liver and other important organ dysfunction;
- those with good compliance, agreed to participate in this clinical study, receive corresponding treatment, and signed the informed consent.
Who cannot join
- Those who do not meet the inclusion criteria or diagnostic criteria, and cannot cooperate with blood sampling and arrangement;
- patients with severe bleeding disorders such as coagulopathy or essential thrombocytopenia;
- local skin ulceration affecting blood drawing, severe rash, or infectious diseases;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sanhuan Cancer Hospital, Chaoyang District, Beijing(Cancer Hospital, Chinese Academy of Medical Sciences, close medical alliance)
Beijing, Beijing Municipality, 100000
zhang yu rong, 010-67487559, shzlyyllwyh@163.com
About this study
For tumor patients, the virus antibody titer produced by the SARS-CoV-2 vaccine is often lower than that of normal people in a short period of time, but in the long run, it can significantly reduce the infection rate and fatality rate of the new coronavirus, and the adverse reactions are mild and there is no significant difference with normal people. However, there is still no real-world research data in China to prove the protective effect of the SARS-CoV-2 vaccine on patients with tumors infected with the SARS-CoV-2 virus.
Read the detailed description
To explore the protective effect of SARS-CoV-2 vaccination on cancer patients infected with SARS-CoV-2. Serum samples were collected from cancer patients who had been infected with SARS-CoV-2 and were previously vaccinated or unvaccinated. The SARS-CoV-2 antibodies (IgG and IgM concentrations) were detected by micro-magnetic particle chemiluminescence method, and the differences were compared. The results of this real-world prospective cohort study can be used to guide the vaccination of cancer patients in clinical practice.
- Conditions
- COVID-19 Infection, COVID-19 Vaccine
- Being tested
- no intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients with SARS-CoV-2 vaccination | Cancer patients with SARS-CoV-2 vaccination Receives: Other: no intervention | |
| Cancer patients without SARS-CoV-2 vaccination | Cancer patients without SARS-CoV-2 vaccination Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SARS-CoV-2 antibodies of all patients
Detection of SARS-CoV-2 antibodies (IgG and IgM concentrations) by micro-magnetic particle chemiluminescence method of all patients
Measured: 2022.12-2022.6 Clear experimental scheme;Serum antibody detection and data collection were completed 2022.7-2022.8 The follow-up data analysis was completed 2022.8-2022.9 Conduct the writing and submission of the paper
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yuan peng, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774171
- Sponsor's protocol ID
- SH-2022018
- Status last verified
- Jan 2023
- First submitted
- 7 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.
PubMed 40237463
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
- To Explore the Protective Effect of SARS-CoV-2 Vaccination on Cancer Patients Infected With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05774171
- Acronym / sponsor ID
- SH-2022018
- Conditions
- COVID-19 Infection, COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Mar 2023 (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.
For tumor patients, the virus antibody titer produced by the SARS-CoV-2 vaccine is often lower than that of normal people in a short period of time, but in the long run, it can significantly reduce the infection rate and fatality rate of the new coronavirus, and the adverse reactions are mild and there is no significant difference with normal people. However, there is still no real-world research data in China to prove the protective effect of the SARS-CoV-2 vaccine on patients with tumors infected with the SARS-CoV-2 virus.
Detailed description
To explore the protective effect of SARS-CoV-2 vaccination on cancer patients infected with SARS-CoV-2. Serum samples were collected from cancer patients who had been infected with SARS-CoV-2 and were previously vaccinated or unvaccinated. The SARS-CoV-2 antibodies (IgG and IgM concentrations) were detected by micro-magnetic particle chemiluminescence method, and the differences were compared. The results of this real-world prospective cohort study can be used to guide the vaccination of cancer patients in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients with SARS-CoV-2 vaccination | – | Other: no interventionCancer patients with SARS-CoV-2 vaccination |
| Cancer patients without SARS-CoV-2 vaccination | – | Other: no interventionCancer patients without SARS-CoV-2 vaccination |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. age > 18 years old, regardless of gender; 2. patients with previous or current tumor, regardless of tumor type; 3. have a history or current infection with SARS-CoV-2; 4. The vital signs were stable, without severe pulmonary, heart, liver and other important organ dysfunction; 5. those with good compliance, agreed to participate in this clinical study, receive corresponding treatment, and signed the informed consent.
Key inclusion criteria (5 listed)
- age > 18 years old, regardless of gender;
- patients with previous or current tumor, regardless of tumor type;
- have a history or current infection with SARS-CoV-2;
- The vital signs were stable, without severe pulmonary, heart, liver and other important organ dysfunction;
- those with good compliance, agreed to participate in this clinical study, receive corresponding treatment, and signed the informed consent.
Key exclusion criteria (3 listed)
- Those who do not meet the inclusion criteria or diagnostic criteria, and cannot cooperate with blood sampling and arrangement;
- patients with severe bleeding disorders such as coagulopathy or essential thrombocytopenia;
- local skin ulceration affecting blood drawing, severe rash, or infectious diseases;
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 |
|---|---|---|
| no interventionno intervention | Other | Cancer patients with SARS-CoV-2 vaccination, Cancer patients without SARS-CoV-2 vaccination |
Primary outcome
Detection of SARS-CoV-2 antibodies of all patients
Time frame: 2022.12-2022.6 Clear experimental scheme;Serum antibody detection and data collection were completed 2022.7-2022.8 The follow-up data analysis was completed 2022.8-2022.9 Conduct the writing and submission of the paper
Detection of SARS-CoV-2 antibodies (IgG and IgM concentrations) by micro-magnetic particle chemiluminescence method of all patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 40237463Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.
- Individual participant dataSharing planned: No
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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.
yuan peng, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 COVID-19 Infection and COVID-19 Vaccine, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 5 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yang zi xuan (18801349043, 2573100063@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of SARS-CoV-2 antibodies of all patients (time frame: 2022.12-2022.6 Clear experimental scheme;Serum antibody detection and data collection were completed 2022.7-2022.8 The follow-up data analysis was completed 2022.8-2022.9 Conduct the writing and submission of the paper). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774171, which also lists 1 linked publication.
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.