NCT05774171

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 17, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

March 7, 2023

Last Update Submit

March 7, 2023

Conditions

COVID-19 InfectionCOVID-19 Vaccine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Cancer patients with SARS-CoV-2 vaccination

Cancer patients with SARS-CoV-2 vaccination

Other: no intervention

Cancer patients without SARS-CoV-2 vaccination

Cancer patients without SARS-CoV-2 vaccination

Other: no intervention

Interventions

no interventionOTHER

no intervention

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • age \> 18 years old, regardless of gender;
  • patients with previous or current tumor, regardless of tumor type;
  • have a history or current infection with SARS-CoV-2;
  • The vital signs were stable, without severe pulmonary, heart, liver and other important organ dysfunction;
  • those with good compliance, agreed to participate in this clinical study, receive corresponding treatment, and signed the informed consent.

You may not qualify if:

  • patients with severe bleeding disorders such as coagulopathy or essential thrombocytopenia;
  • local skin ulceration affecting blood drawing, severe rash, or infectious diseases;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40237463DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples were collected from cancer patients who had been infected with SARS-CoV-2, with or without previous SARS-CoV-2 vaccination

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • yuan peng, M.D.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

yang zi xuan

CONTACT

188013490432573100063@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 17, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)