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COVID-19 Vaccination in Oncologic Patients

NCT ID: NCT04918888

Last Updated: 2021-11-23

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

COMPLETED

Total Enrollment

1150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-19

Study Completion Date

2021-09-30

Brief Summary

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Evaluating the vaccination willingness in oncologic patients over six months as well as estimating the effects of radiotherapy/systemic anticancer treatment on the efficacy and toxicity of currently approved SARS-CoV-2 vaccines

Detailed Description

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All patients that present themselves newly at the outpatient-clinic of the Department of Radiooncology at the Ordensklinikum Linz GmbH, Barmherzige Schwestern during a period of six months are eligible for participation. After being informed about the study, the participants answer a short structured interview regarding vaccination status and vaccination willingness. Patients who already received one or two doses of SARS-CoV-2 vaccine are eligible for the study's subpopulation 1, with the main focus of quantifying SARS-CoV-2 S binding antibody titres after at least 35 days from initial vaccination. Patients who are to receive at least one dose of vaccine during or up to six weeks after radiotherapy are eligible for subpopulation 2, comprising serial measurements of SARS-CoV-2 S binding antibody titres before and after vaccination.

Conditions

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Covid19 Oncologic Disorders

Keywords

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radiotherapy SARS-CoV-2 vaccine immune response oncologic therapies immunosuppression SARS-CoV-2 S binding antibodies vaccination willingness vaccination side effects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Overall study population

All new oncologic patients of the outpatient-clinic of the department of radiooncology

No interventions assigned to this group

First dose received (Subpopulation 1)

Patients, who received one or two doses of SARS-CoV-2 vaccine prior to radiotherapy

No interventions assigned to this group

Vaccination during therapy (Subpopulation 2)

Patients, who will receive at least one dose of SARS-CoV-2 vaccine during or up to 6 weeks after radiotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Study population for the cross-sectional study (patients with previous SARS-CoV-2 infection of previous vaccination, evaluation of willingness to get vaccinated:

* Patients with solid tumors/haematooncologic diseases regardless of stage that seek treatment in the outpatient clinic of the department of radiooncology from April to September 2021 who will undergo active treatment.
* Age: 18-120 years Patients that undergo radiotherapy, radio-chemotherapy, radio-hormonotherapy or radio-immunotherapy during the investigation period.

Longitudinal study:

* Patients that have not yet received SARS-CoV-2 vaccination, but are scheduled to get the first dose during or up to six weeks after active therapy.
* Age: 18-120 years

Exclusion Criteria

* Lack of written consent
* Patients, that are mentally or physically incapable of completing a questionnaire
* Age: \< 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Barmherzige Schwestern Linz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Geinitz, Univ.-Prof.

Role: PRINCIPAL_INVESTIGATOR

Ordensklinikum Linz GmbH, Barmherzige Schwestern

Locations

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Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria, Austria

Site Status

Ordensklinikum Linz GmbH, Barmherzige Schwestern

Linz, Upper Austria, Austria

Site Status

Countries

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Austria

References

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Geinitz H, Silberberger E, Spiegl K, Feichtinger J, Wagner H, Hermann P, Brautigam E, Track C, Weis EM, Venhoda C, Huppert R, Spindelbalker-Renner B, Zauner-Babor G, Nyiri DV, Karasek N, Erdei M, Gheju R, Gruber G, Egger M, Dieplinger B. SARS-CoV-2 vaccination willingness and humoral vaccination response in radiation oncology patients. Vaccine. 2024 Feb 6;42(4):945-959. doi: 10.1016/j.vaccine.2024.01.006. Epub 2024 Jan 20.

Reference Type DERIVED
PMID: 38246842 (View on PubMed)

Other Identifiers

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ECS 1048/2021

Identifier Type: -

Identifier Source: org_study_id