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

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 Overview

• Status: Recruiting
• Conditions: COVID-19 Vaccine; COVID-19 Infection
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: yang zi xuan; Phone Number: 18801349043; Email: 2573100063@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Sanhuan Cancer Hospital, Chaoyang District, Beijing(Cancer Hospital, Chinese Academy of Medical Sciences, close medical alliance)
      • Contact: zhang yu rong; Phone Number: 010-67487559; Email: shzlyyllwyh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer patients with SARS-CoV-2 vaccination	Other: no intervention; no intervention
Cancer patients without SARS-CoV-2 vaccination	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: yuan peng, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SH-2022018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No