Clinical trial NCT05774171: To Explore the Protective Effect of SARS-CoV-2 Vaccination on Cancer Patients Infected With SARS-CoV-2
Official title: To Explore the Protective Effect of SARS-CoV-2 Vaccination on Cancer Patients Infected With SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Infection
COVID-19 Vaccine
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. Those who do not meet the inclusion criteria or diagnostic criteria, and cannot cooperate with blood sampling and arrangement;
2. patients with severe bleeding disorders such as coagulopathy or essential thrombocytopenia;
3. local skin ulceration affecting blood drawing, severe rash, or infectious diseases;

Primary outcomes:
measure: Detection of SARS-CoV-2 antibodies of all patients
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sanhuan Cancer Hospital, Chaoyang District, Beijing(Cancer Hospital, Chinese Academy of Medical Sciences, close medical alliance)
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: yuan peng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: