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Trial Title:
To Explore the Protective Effect of SARS-CoV-2 Vaccination on Cancer Patients Infected With SARS-CoV-2
NCT ID:
NCT05774171
Condition:
COVID-19 Infection
COVID-19 Vaccine
Conditions: Official terms:
COVID-19
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
no intervention
Description:
no intervention
Arm group label:
Cancer patients with SARS-CoV-2 vaccination
Arm group label:
Cancer patients without SARS-CoV-2 vaccination
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sanhuan Cancer Hospital, Chaoyang District, Beijing(Cancer Hospital, Chinese Academy of Medical Sciences, close medical alliance)
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
zhang yu rong
Phone:
010-67487559
Email:
shzlyyllwyh@163.com
Start date:
January 1, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05774171
