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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04918888
Other study ID # ECS 1048/2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 19, 2021
Est. completion date September 30, 2021

Study information

Verified date November 2021
Source Krankenhaus Barmherzige Schwestern Linz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 1150
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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 - A previous SARS-CoV-2 infection is no exclusion criteria!

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern Linz Upper Austria
Austria Ordensklinikum Linz GmbH, Barmherzige Schwestern Linz Oberösterreich

Sponsors (1)

Lead Sponsor Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantification of vaccination willingness guided interview once directly after enrollment
Secondary SARS-CoV-2 antibody titre in already vaccinated patients >= 35 days post first dose
Secondary SARS-CoV-2 antibody titre in patients vaccinated during antineoplastic treatment Development of antibody titre in patients who received the first or second dose of SARS-CoV-2 vaccine during radiotherapy, Longitudinal quantification of binding antibodies baseline and 7, 14,21,28,35, 182 and 365 days post first dose
Secondary Qualitive assessment of reasons to reject vaccination guided interview once directly after enrollment
Secondary Qualitive assessment of comorbidities (in respect of the gravity of a SARS-CoV-2 infection corresponding to the WHO-grading), guided interview once after enrollment prior to vaccination
Secondary Kind and dosage of accompanying systemic therapies once after enrollment
Secondary Modalities and duration of the radiotherapy (irradiated region, single dose overall dose) once after enrollment
Secondary Previous SARS-CoV-2 infection (Rate of undetected cases via antibody detection, for known previous disease: evaluation of severity) guided interview, conducted again at day 35 after the first dose for patients who receive radiotherapy during the first dose of vaccination once directly after enrollment and ev. at >= 35 days after first dose
Secondary Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination questionnaire 35 days after vaccination
Secondary incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity) questionnaire 35 days after vaccination
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