Evaluating a new patient-reported outcome measure for glioma patients in China
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
This study is testing a new way for glioma patients in China to report their symptoms during treatment to see if it accurately reflects their experiences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 17 sites (Beijing, Beijing and 16 other locations) |
| Trial ID | NCT05486923 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the validity and reliability of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) specifically for adult-type diffuse glioma patients in China. Initially, a consensus will be reached among experts to determine relevant symptom terms through a Delphi survey. Following this, a prospective, multi-center observational study will be conducted to evaluate the customized PRO-CTCAE™ in approximately 450 patients, focusing on their experiences during anti-tumor treatment. The study will utilize the Karnofsky Performance Status (KPS) as a benchmark for patient assessment.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 to 85 with a pathologically diagnosed adult diffuse glioma who are undergoing anti-tumor treatment.
Not a fit: Patients who have already received non-surgical treatment since their diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of patient-reported outcomes in glioma treatment, leading to improved patient care.
How similar studies have performed: While the use of PRO-CTCAE™ has been explored in other oncology settings, this specific application in glioma patients is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing and 16 other locations
- Beijing Tian Tan Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
- Tsinghua Changgung Hospital — Beijing, Beijing, China (Withdrawn)
- Xuan Wu Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Withdrawn)
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
- Guangdong Sanjiu Brain Hospital — Guangzhou, Guangdong, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Wuhan, Hubei, China (Recruiting)
- Jiangsu People's Hospital — Nanjing, Jiangsu, China (Recruiting)
- The General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Withdrawn)
- Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
- Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University — Shanghai, Shanghai, China (Recruiting)
- Changhai Hospital — Shanghai, Shanghai, China (Recruiting)
- East Hospital Affiliated To Tongji University — Shanghai, Shanghai, China (Recruiting)
- Shanghai Proton and Heavy Ion Hospital — Shanghai, Shanghai, China (Recruiting)
- The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
- The Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Jinsong Wu, Ph.D. & M.D.
- Email: wjsongc@126.com
- Phone: +86-21-52887200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.