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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05774171
Collaborator
(none)
700
1
12
58.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
700 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
To Explore the Protective Effect of SARS-CoV-2 Vaccination on Cancer Patients Infected With SARS-CoV-2
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Cancer patients with SARS-CoV-2 vaccination

Cancer patients with SARS-CoV-2 vaccination

Other: no intervention
no intervention

Cancer patients without SARS-CoV-2 vaccination

Cancer patients without SARS-CoV-2 vaccination

Other: no intervention
no intervention

Outcome Measures

Primary Outcome Measures

  1. Detection of SARS-CoV-2 antibodies 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]

    Detection of SARS-CoV-2 antibodies (IgG and IgM concentrations) by micro-magnetic particle chemiluminescence method of all patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanhuan Cancer Hospital, Chaoyang District, Beijing(Cancer Hospital, Chinese Academy of Medical Sciences, close medical alliance) Beijing Beijing China 100000

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05774171
Other Study ID Numbers:
  • SH-2022018
First Posted:
Mar 17, 2023
Last Update Posted:
Mar 17, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2023