Radiotherapy Side EffectPEDRONCT05224297
Patient Experience Data in Radiation Oncology
An observational study of Radiotherapy Side Effect and PROMs, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The project is part of the overarching goal of improving patient-centric radiation oncology. This pilot project aims to develop an instrument that can be used to collect clinically relevant patient-reported outcome data on adverse effects during and after RT. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radiotherapy Side Effect, PROMs
- What is being tested?
- external beam photon therapy
- Type of treatment
- Surgery or procedure
- How many people
- 6,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2020to 1 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is aimed to include a comprehensive representative cross-section for each of the study groups.
Who may be able to join
- all patients receiving external beam radiotherapy
Who cannot join
- unable to independently answer questionnaires on radiation-induced side effects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Gerd Heilemann, PhD
Andreas Renner, PhD
About this study
The project is part of the overarching goal of improving patient-centric radiation oncology. This pilot project aims to develop an instrument that can be used to collect clinically relevant patient-reported outcome data on adverse effects during and after RT. This real-world evidence (RWE) database will be the basis to monitor and evaluate future technological developments, combination treatments (e.g. radioimmunotherapy, etc.), or changes in treatment protocols. The pseudonymized data will be linked to data in the oncological information system and dosimetric data from the treatment planning system. In this way, they represent a basic building block of patient-oriented development of clinical radiotherapy.
- Conditions
- Radiotherapy Side Effect, PROMs
- Being tested
- external beam photon therapy
- Keywords
- radiation oncology, patient reported outcome
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external beam photon therapyRadiation
Patients receive external beam photon therapy for different tumor locations (groups).
| Study group | Role | What they receive |
|---|---|---|
| breast | Not described Receives: Radiation: external beam photon therapy | |
| thorax | Not described Receives: Radiation: external beam photon therapy | |
| skin | Not described Receives: Radiation: external beam photon therapy | |
| abdomen | Not described Receives: Radiation: external beam photon therapy | |
| skull | Not described Receives: Radiation: external beam photon therapy | |
| head and neck | Not described Receives: Radiation: external beam photon therapy | |
| pelvis male | Not described Receives: Radiation: external beam photon therapy | |
| pelvis female | Not described Receives: Radiation: external beam photon therapy | |
| extremities | Not described Receives: Radiation: external beam photon therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiation-related side effects
Measured: during radiotherapy and after (up until 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Oct 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerd Heilemann, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224297
- Sponsor's protocol ID
- 2184/2019
- Acronym
- PEDRO
- Status last verified
- Nov 2024
- First submitted
- 25 Jan 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experience Data in Radiation Oncology
- ClinicalTrials.gov ID
- NCT05224297
- Acronym / sponsor ID
- PEDRO / 2184/2019
- Conditions
- Radiotherapy Side Effect, PROMs
- Keywords
- radiation oncology, patient reported outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is part of the overarching goal of improving patient-centric radiation oncology. This pilot project aims to develop an instrument that can be used to collect clinically relevant patient-reported outcome data on adverse effects during and after RT. This real-world evidence (RWE) database will be the basis to monitor and evaluate future technological developments, combination treatments (e.g. radioimmunotherapy, etc.), or changes in treatment protocols. The pseudonymized data will be linked to data in the oncological information system and dosimetric data from the treatment planning system. In this way, they represent a basic building block of patient-oriented development of clinical radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| breast | – | Radiation: external beam photon therapy |
| thorax | – | Radiation: external beam photon therapy |
| skin | – | Radiation: external beam photon therapy |
| abdomen | – | Radiation: external beam photon therapy |
| skull | – | Radiation: external beam photon therapy |
| head and neck | – | Radiation: external beam photon therapy |
| pelvis male | – | Radiation: external beam photon therapy |
| pelvis female | – | Radiation: external beam photon therapy |
| extremities | – | Radiation: external beam photon therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is aimed to include a comprehensive representative cross-section for each of the study groups.
Key inclusion criteria (1 listed)
- all patients receiving external beam radiotherapy
Key exclusion criteria (1 listed)
- unable to independently answer questionnaires on radiation-induced side effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external beam photon therapyPatients receive external beam photon therapy for different tumor locations (groups). | Radiation | abdomen, breast, extremities, head and neck, pelvis female, pelvis male, skin, skull, thorax |
Primary outcome
radiation-related side effects
Time frame: during radiotherapy and after (up until 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy Side Effect and PROMs, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerd Heilemann, PhD (004314040072710, gerd.heilemann@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiation-related side effects (time frame: during radiotherapy and after (up until 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.