Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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-CTCAEâ„¢) 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-CTCAEâ„¢ 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-CTCAEâ„¢ for adult-type diffuse gliomas patients in Chinese population will be launched (VERONICA).
First, based on information queries, expert consultation research, online Delphi survey, and survey data analysis, the investigators will determine the questionnaire terms for PRO-CTCAEâ„¢ for adult-type diffuse gliomas patients.
A total of 16 experts (13 neurosurgeons, 2 radiotherapists, 1 psychiatrist) from 14 medical centers in China were invited to participate in a consensus-seeking 2-round online Delphi survey. Participants rated the level of their agreement with each symptom term likely to occur during adult diffuse gliomas treatment on a 5-point Likert scale. Terms not reaching consensus over the first round were modified in the second rounds. Consensus was defined as content validity index (CVI) >0.78,coefficient of variation (CV)< 0.35 and average Likert score >3.00.
Second, a prospective, multi-center, real-world study would be performed to assess the validity, reliability, and responsiveness of the customized PRO-CTCAEâ„¢ for adult diffuse glioma patients in Chinese population.
This study is an observational, prospective, open-label clinical study. It is estimated that 450 adult diffuse glioma patients will be recruited from 17 research centers, and participants will be included in the cohort in chronological order until the target number of cases is reached. The study is expected to be completed within 2 years. In this study, KPS will be used as the anchor point to compare two groups of patients(KPS≤70 and KPS>70, patients with KPS≤70 is not less than 15%).
The investigators do not intervene in the current treatment plan for patients, only observe the treatment plan, and conduct regular questionnaires on the patients: since the patients are enrolled (within 42 days after surgery), six basic follow-ups and long-term follow-ups will be carried out. The whole follow-ups will last for two years.
The follow-up contents include:
Filled out by doctors: demographic information, diagnosis information, anti-tumor treatment (in the past 2 weeks), special treatment (in the past 2 weeks, including but not limited to dehydration drugs and psychotropic drugs, etc.), CTCAE v5.0 (only including the items corresponding to PRO-CTCAEâ„¢), KPS.
Filled out by patients: customized PRO-CTCAETM, QLQ-C30, GIC.
Data will be collected using EDC system to ensure patient privacy and data integrity.
The statistical analysis methods:
For the customized PRO-CTCAEâ„¢, quantitatively assign each item and its answers (F, S, A, I, P), and then use statistical methods to assess the validity, reliability, and responsiveness of the customized PRO-CTCAEâ„¢ for adult diffuse glioma patients in Chinese population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPS less than 70 | 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. | ||
| KPS more than 70 | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| the validity, reliability, and responsiveness of the customized PRO-CTCAEâ„¢ for adult-type diffuse gliomas patients in Chinese population | The investigators will compare the customized PRO-CTCAEâ„¢ measurements at multiple visits and test the correlation between PRO-CTCAEâ„¢, QLQ-C30 and KPS scores, to access the validity, reliability, and responsiveness of the customized PRO-CTCAEâ„¢ for adult-type diffuse gliomas patients in Chinese population. | December 1, 2025 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adult diffuse glioma patients aged 18 to 85 years who have not received the first non-surgical treatment after diagnosis/recurrent.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jinsong Wu, Ph.D. & M.D. | Huashan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tian Tan Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Xuan Wu Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24101048 | Background | Armstrong 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. | |
| 24552317 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Beijing |
| Beijing Municipality |
| China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| Guangdong Sanjiu Brain Hospital | Guangzhou | Guangdong | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei | China |
| Jiangsu People's Hospital | Nanjing | Jiangsu | China |
| Xijing Hospital | Xi'an | Shaanxi | China |
| Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Changhai Hospital | Shanghai | Shanghai Municipality | China |
| East Hospital Affiliated To Tongji University | Shanghai | Shanghai Municipality | China |
| Shanghai Proton and Heavy Ion Hospital | Shanghai | Shanghai Municipality | China |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| The Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| Background |
| Gilbert 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. |
| 26644527 | Background | Basch 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. |
| 32007210 | Result | Armstrong 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. |
| 26181187 | Result | Basch 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. |
| 29294069 | Result | Cagney DN, Sul J, Huang RY, Ligon KL, Wen PY, Alexander BM. The FDA NIH Biomarkers, EndpointS, and other Tools (BEST) resource in neuro-oncology. Neuro Oncol. 2018 Aug 2;20(9):1162-1172. doi: 10.1093/neuonc/nox242. |
| 26989127 | Result | Armstrong TS, Bishof AM, Brown PD, Klein M, Taphoorn MJ, Theodore-Oklota C. Determining priority signs and symptoms for use as clinical outcomes assessments in trials including patients with malignant gliomas: Panel 1 Report. Neuro Oncol. 2016 Mar;18 Suppl 2(Suppl 2):ii1-ii12. doi: 10.1093/neuonc/nov267. |
| 32073955 | Result | Yeung AR, Pugh SL, Klopp AH, Gil KM, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Bruner DW, Kachnic LA. Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study. J Clin Oncol. 2020 May 20;38(15):1685-1692. doi: 10.1200/JCO.19.02381. Epub 2020 Feb 19. |
| 25265940 | Result | Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014 Sep 29;106(9):dju244. doi: 10.1093/jnci/dju244. Print 2014 Sep. |
| 26270597 | Result | Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson TM, Bennett AV, Denicoff AM, O'Mara AM, Li Y, Clauser SB, Bryant DM, Bearden JD 3rd, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E; National Cancer Institute PRO-CTCAE Study Group. Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 2015 Nov;1(8):1051-9. doi: 10.1001/jamaoncol.2015.2639. |
| 30230365 | Result | Trask PC, Dueck AC, Piault E, Campbell A. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials. Clin Trials. 2018 Dec;15(6):616-623. doi: 10.1177/1740774518799985. Epub 2018 Sep 19. |
| 42011212 | Derived | Song S, Wang X, Cao X, Luo C, Na K, Guo C, Xu J, Nie M, Li C, Huang Q, Li S, Wang H, Wang H, Liu M, Wang Y, Sun C, Xiong Z, Wu Z, Sun Y, Ni C, Zhang W, Wu Z, Chen S, Zou Y, Sun X, Ma H, Zhang J, Zhong C, Chen J, Fei Z, Kong L, You Y, Shen J, Cao Y, Zhang L, Wu S, Yao Y, Shu K, Qiu X, Tang J, Mou Y, Tang Z, Cai L, Zhang J, Wu J. Development and validation of a customised PRO-CTCAE scale for adult-type diffuse gliomas (VERONICA): a multicentre, prospective, observational cohort study in China. EClinicalMedicine. 2026 Apr 10;94:103879. doi: 10.1016/j.eclinm.2026.103879. eCollection 2026 Apr. |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided