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

July 20, 2025 updated by: Jinsong Wu, Huashan Hospital

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Tian Tan Hospital, Capital Medical University
      • Beijing, Beijing, China
        • Xuan Wu Hospital, Capital Medical University
    • Fujian
      • Fuzhou, Fujian, China
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen University Cancer Center
      • Guangzhou, Guangdong, China
        • Guangdong Sanjiu Brain Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu People's Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Xijing Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Changhai Hospital
      • Shanghai, Shanghai, China, 200040
        • Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University
      • Shanghai, Shanghai, China
        • East Hospital Affiliated To Tongji University
      • Shanghai, Shanghai, China
        • Shanghai Proton and Heavy Ion Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • The First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult diffuse glioma patients aged 18 to 85 years who have not received the first non-surgical treatment after diagnosis/recurrent.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult-type diffuse gliomas patients in Chinese population
Time Frame: December 1, 2025
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.
December 1, 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Study Chair: Jinsong Wu, Ph.D. & M.D., Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2022

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 20, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2022-681

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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