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

NCT ID: NCT05774171

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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COVID-19 Infection COVID-19 Vaccine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer patients with SARS-CoV-2 vaccination

Cancer patients with SARS-CoV-2 vaccination

no intervention

Intervention Type OTHER

no intervention

Cancer patients without SARS-CoV-2 vaccination

Cancer patients without SARS-CoV-2 vaccination

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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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.

2. patients with severe bleeding disorders such as coagulopathy or essential thrombocytopenia;
3. local skin ulceration affecting blood drawing, severe rash, or infectious diseases;
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yuan peng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Sanhuan Cancer Hospital, Chaoyang District, Beijing(Cancer Hospital, Chinese Academy of Medical Sciences, close medical alliance)

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yang zi xuan

Role: CONTACT

18801349043

Facility Contacts

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zhang yu rong

Role: primary

010-67487559

References

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Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.

Reference Type DERIVED
PMID: 40237463 (View on PubMed)

Other Identifiers

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SH-2022018

Identifier Type: -

Identifier Source: org_study_id

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