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NCT05486923: VERONICA
Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese Population
trial in Glioma in 450 participants. Completed in 1 February 2025.
1 January 2025
Quick facts
| Lead sponsor | Huashan Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 450 |
| Start date | 19 September 2022 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 February 2025 |
| Sites | 14 locations across China |
Conditions studied
- Glioma — all drugs for Glioma →
- Patient Reported Outcome Measures — all drugs for Patient Reported Outcome Measures →
- Self Report — all drugs for Self Report →
- Adverse Effects — all drugs for Adverse Effects →
Sponsor
Huashan Hospital
Who can join
Adults 18 to 85, any sex, with Glioma or Patient Reported Outcome Measures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Given the increasing importance of patient's perspective in adverse events reporting, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) has been proposed as new PRO measures in oncology; however, its implementation has not yet been evaluated in glioma patients, and standardized selection process of priority symptom terms has not been applied. The study focuses on Chinese adult-type diffuse glioma patients. First, based on information queries, expert consultation research, online Delphi survey, and survey data analysis, the investigators will determine the questionnaire terms for PRO-CTCAE™ for adult-type diffuse gliomas patients. In the next stage, a prospective, multi-center, real-world study to assess the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult-type diffuse gliomas patients in Chinese population will be launched (VERONICA).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Development and validation of a customised PRO-CTCAE scale for adult-type diffuse gliomas (VERONICA): a multicentre, prospective, observational cohort study in China.
Song S, Wang X, Cao X, Luo C, et al · · 2026 · PMID 42011212 · DOI 10.1016/j.eclinm.2026.103879
Verify or expand the search:
- PubMed search for NCT05486923
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Huashan Hospital trials
Trials by the same sponsor.
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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 NCT05486923 (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 Huashan Hospital
- Last refreshed: 24 July 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/NCT05486923.
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