To Explore the Protective Effect of SARS-CoV-2 Vaccination on Cancer Patients Infected With SARS-CoV-2

Overview

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.

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: December 31, 2023

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.

Interventions

• Other: no intervention
  • no intervention

Arms, Groups and Cohorts

• Cancer patients with SARS-CoV-2 vaccination
  • Cancer patients with SARS-CoV-2 vaccination
• Cancer patients without SARS-CoV-2 vaccination
  • Cancer patients without SARS-CoV-2 vaccination

Clinical Trial Outcome Measures

Primary Measures

• 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

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • yuan peng, M.D., Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Overall Contact(s)
  • yang zi xuan, 18801349043, 2573100063@qq.com