GliomaVERONICANCT05486923
Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese Population
An observational study of Glioma and Patient Reported Outcome Measures, run by Huashan Hospital at 14 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glioma, Patient Reported Outcome Measures, Self Report
- How many people
- 450 participants
- Where
- 14 sitesChina
- Study dates
- 19 Sep 2022to 1 Feb 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult diffuse glioma patients aged 18 to 85 years who have not received the first non-surgical treatment after diagnosis/recurrent.
Who may be able to join
- 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).
- For newly diagnosed patients, the patient has not received the first non-surgical treatment.
- For recurrent patients, the patient has not received the first non-surgical treatment after the recurrence.
- 18 to 85 years old.
- No significant cognitive impairment based on researchers' judgment.
- 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.
- Patients are undergoing anti-tumor treatment and continue to receive treatment within the next 28 days.
- Patients sign written informed consent.
Who cannot join
- Patients who are not considered suitable for this study.
- Since the diagnosis, the patient has undergone non-surgical treatment.
- Patients fail to complete the questionnaire within 42 days of signing informed consent.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality
Xuan Wu Hospital, Capital Medical University
Beijing, Beijing Municipality
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Guangdong Sanjiu Brain Hospital
Guangzhou, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Jiangsu People's Hospital
Nanjing, Jiangsu
Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, 200040
Changhai Hospital
Shanghai, Shanghai Municipality
East Hospital Affiliated To Tongji University
Shanghai, Shanghai Municipality
Shanghai Proton and Heavy Ion Hospital
Shanghai, Shanghai Municipality
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei
Xijing Hospital
Xi'an, Shaanxi
About this study
Official title: 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
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).
Read the detailed description
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.
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-CTCAE™ 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-CTCAE™), 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-CTCAE™, 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-CTCAE™ for adult diffuse glioma patients in Chinese population.
- Keywords
- Glioma, China, Patient Reported Outcome Measures, Self Report, Humans, Adverse effects, Adult, Surveys and Questionnaires, Research Design
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult-type diffuse gliomas patients in Chinese population
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.
Measured: December 1, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start19 Sep 2022
- Primary completion1 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsong Wu, Huashan Hospital
- Investigators
- Jinsong Wu, Ph.D. & M.D., Study chair, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486923
- Sponsor's protocol ID
- KY2022-681
- Acronym
- VERONICA
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24101048Gilbert 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.
PubMed 24552317Basch 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.
PubMed 26644527Armstrong 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.
PubMed 32007210Basch 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.
PubMed 26181187Cagney 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.
PubMed 29294069Armstrong 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.
PubMed 26989127Yeung 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.
PubMed 32073955Basch 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.
PubMed 25265940Dueck 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.
PubMed 26270597Trask 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.
PubMed 30230365Song 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.
PubMed 42011212