Glioma Clinical Trial
— VERONICAOfficial 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
NCT number | NCT05486923 |
Other study ID # | KY2022-681 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 19, 2022 |
Est. completion date | June 1, 2024 |
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).
Status | Recruiting |
Enrollment | 450 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tian Tan Hospital, Capital Medical University | Beijing | Beijing |
China | Tsinghua Changgung Hospital | Beijing | Beijing |
China | Xuan Wu Hospital, Capital Medical University | Beijing | Beijing |
China | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
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 | The Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
China | The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan |
China | Jiangsu People's Hospital | Nanjing | Jiangsu |
China | Changhai Hospital | Shanghai | Shanghai |
China | 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 | Shanghai | Shanghai |
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei |
China | Xijing Hospital | Xi'an | Shaanxi |
China | The General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | June 1, 2024 |
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