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Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese Population

NCT05486923 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2025-07-24

No results posted yet for this study

Summary

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).

Conditions

  • Glioma
  • Patient Reported Outcome Measures
  • Self Report
  • Adverse Effects

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Jinsong Wu, Ph.D. & M.D. · Huashan Hospital

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2025-01-01
Completion
2025-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05486923 on ClinicalTrials.gov