NCT04918888

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,150

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

April 19, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

June 4, 2021

Last Update Submit

November 22, 2021

Conditions

Covid19Oncologic Disorders

Keywords

radiotherapySARS-CoV-2 vaccineimmune responseoncologic therapiesimmunosuppressionSARS-CoV-2 S binding antibodiesvaccination willingnessvaccination side effects

Outcome Measures

Primary Outcomes (1)

  • Quantification of vaccination willingness

    guided interview

    once directly after enrollment

Secondary Outcomes (9)

  • SARS-CoV-2 antibody titre in already vaccinated patients

    >= 35 days post first dose

  • SARS-CoV-2 antibody titre in patients vaccinated during antineoplastic treatment

    baseline and 7, 14,21,28,35, 182 and 365 days post first dose

  • Qualitive assessment of reasons to reject vaccination

    once directly after enrollment

  • Qualitive assessment of comorbidities

    once after enrollment prior to vaccination

  • Kind and dosage of accompanying systemic therapies

    once after enrollment

  • +4 more secondary outcomes

Study Arms (3)

Overall study population

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

First dose received (Subpopulation 1)

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

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

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

new patients of the department for radiooncology at the Ordensklinikum Barmherzige Schwestern Linz

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria, 4010, Austria

Location

Ordensklinikum Linz GmbH, Barmherzige Schwestern

Linz, Upper Austria, 4010, Austria

Location

Related Publications (1)

  • 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.

    PMID: 38246842DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hans Geinitz, Univ.-Prof.

    Ordensklinikum Linz GmbH, Barmherzige Schwestern

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 9, 2021

Study Start

April 19, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

AU(2)