Clinical trial · Observational
Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese Population
Validity and Reliability Evaluation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for Adult-type Diffuse Gliomas Patients in Chinese Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Effects | — | UNRESOLVED | — |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Patient Reported Outcome Measures | — | UNRESOLVED | — |
| Self Report | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- KPS less than 70
- description
- The patients in this group have Karnofsky performance Status less than 70，and the proportion of them is not less than 15%. Patients need regular follow-up surveys within 2 years after the date of surgery.
- label
- KPS more than 70
- description
- The patients in this group have Karnofsky performance Status more than 70. Patients need regular follow-up surveys within 2 years after the date of surgery.
Primary outcomes (1)
- measure
- the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult-type diffuse gliomas patients in Chinese population
- timeFrame
- December 1, 2025
- description
- The investigators will compare the customized PRO-CTCAE™ measurements at multiple visits and test the correlation between PRO-CTCAE™, QLQ-C30 and KPS scores, to access the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult-type diffuse gliomas patients in Chinese population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically diagnosed adult diffuse glioma patients( including astrocytoma, IDH-mutant; oligodendroglioma, IDH-mutant and1p/19q-codeleted; glioblastoma, IDH-wildtype; other adult diffuse glioma NEC/NOS). 2. For newly diagnosed patients, the patient has not received the first non-surgical treatment. 3. For recurrent patients, the patient has not received the first non-surgical treatment after the recurrence. 4. 18 to 85 years old. 5. No significant cognitive impairment based on researchers' judgment. 6. Patients can use mobile phones or computers on their own or with the help of others, read and understand Chinese, at least with primary school culture. 7. Patients are undergoing anti-tumor treatment and continue to receive treatment within the next 28 days. 8. Patients sign written informed consent. Exclusion Criteria: 1. Patients who are not considered suitable for this study. 2. Since the diagnosis, the patient has undergone non-surgical treatment. 3. Patients fail to complete the questionnaire within 42 days of signing informed consent.
References
Publications (12)
- BACKGROUNDArmstrong TS, Wefel JS, Wang M, Gilbert MR, Won M, Bottomley A, Mendoza TR, Coens C, Werner-Wasik M, Brachman DG, Choucair AK, Mehta M. Net clinical benefit analysis of radiation therapy oncology group 0525: a phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma. J Clin Oncol. 2013 Nov 10;31(32):4076-84. doi: 10.1200/JCO.2013.49.6067. Epub 2013 Oct 7. PMID 24101048
- BACKGROUNDGilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573. PMID 24552317
- BACKGROUNDBasch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. PMID 26644527
- RESULTArmstrong TS, Dirven L, Arons D, Bates A, Chang SM, Coens C, Espinasse C, Gilbert MR, Jenkinson D, Kluetz P, Mendoza T, Rubinstein L, Sul J, Weller M, Wen PY, van den Bent MJ, Taphoorn MJB. Glioma patient-reported outcome assessment in clinical care and research: a Response Assessment in Neuro-Oncology collaborative report. Lancet Oncol. 2020 Feb;21(2):e97-e103. doi: 10.1016/S1470-2045(19)30796-X. PMID 32007210
- RESULTBasch E, Geoghegan C, Coons SJ, Gnanasakthy A, Slagle AF, Papadopoulos EJ, Kluetz PG. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient. JAMA Oncol. 2015 Jun;1(3):375-9. doi: 10.1001/jamaoncol.2015.0530. PMID 26181187