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OpenTrials
Completed

NCT Number: NCT04918888

COVID-19 Vaccination in Oncologic Patients

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

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, Upper Austria, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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!

Treatment and study plan

Primary outcomes

  1. Quantification of vaccination willingness

    Time frame: once directly after enrollment

    guided interview

Secondary outcomes

  1. SARS-CoV-2 antibody titre in already vaccinated patients

    Time frame: >= 35 days post first dose

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

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

    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

  3. Qualitive assessment of reasons to reject vaccination

    Time frame: once directly after enrollment

    guided interview

  4. Qualitive assessment of comorbidities

    Time frame: once after enrollment prior to vaccination

    (in respect of the gravity of a SARS-CoV-2 infection corresponding to the WHO-grading), guided interview

  5. Kind and dosage of accompanying systemic therapies

    Time frame: once after enrollment

  6. Modalities and duration of the radiotherapy (irradiated region, single dose overall dose)

    Time frame: once after enrollment

  7. Previous SARS-CoV-2 infection (Rate of undetected cases via antibody detection, for known previous disease: evaluation of severity)

    Time frame: once directly after enrollment and ev. at >= 35 days after first dose

    guided interview, conducted again at day 35 after the first dose for patients who receive radiotherapy during the first dose of vaccination

  8. Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination

    Time frame: 35 days after vaccination

    questionnaire

  9. incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity)

    Time frame: 35 days after vaccination

    questionnaire

Sponsors and collaborators

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Other

Registry information

Official study title

SARS-CoV-2 Vaccination in Oncologic Patients: A Prospective, Explorative Study

Acronym: VINCI

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2021
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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