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NCT04066868
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
NA trial testing Patient-reported outcomes assessment in Cancer in 1,013 participants. Completed in 6 December 2024.
6 December 2024
Quick facts
| Lead sponsor | Medical University Innsbruck |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1,013 |
| Start date | 10 February 2020 |
| Primary completion | 6 December 2024 |
| Estimated completion | 6 December 2024 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Patient-reported outcomes assessment
- CTCAE rating
- PRO data is displayed
Conditions studied
- Cancer — all drugs for Cancer →
Sponsor
Medical University Innsbruck
Who can join
18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This open randomized trial investigates, if clinicians complete CTCAE ratings differently when receiving patients' patient-reported outcome (PRO) data prior to their CTCAE completion. The primary objective is to demonstrate superior inter-rater reliability of CTCAE ratings from physicians relying on EORTC PRO data as additional data source over traditional CTCAE ratings not including PRO information.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice.
Gibbons C, Porter I, Gonçalves-Bradley DC, Stoilov S, et al · · 2021 · cited 146× · PMID 34637526 · DOI 10.1002/14651858.cd011589.pub2 -
Inter-rater reliability of CTCAE assessments with or without EORTC patient-reported outcome data in a mixed cancer population: a multinational, open-label, randomised controlled trial.
Wintner LM, Sztankay M, Abdel-Razeq H, Hamdan-Mansour R, et al · · 2026 · cited 3× · PMID 41570841 · DOI 10.1016/s1470-2045(25)00679-5 -
Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial.
Wintner LM, Giesinger JM, Sztankay M, Bottomley A, et al · · 2020 · cited 2× · PMID 33050917 · DOI 10.1186/s13063-020-04745-w
Verify or expand the search:
- PubMed search for NCT04066868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04066868 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University Innsbruck
- Last refreshed: 20 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04066868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing