Skip to content

Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas 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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109631
Enrollment
Unknown
Registered
2025-09-23
Start date
2022-09-02
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult diffuse glioma: including astrocytoma, IDH-mutant

Interventions

KPS less than 70:NA
KPS more than 70:NA

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Pathologically diagnosed adult diffuse glioma patients( including astrocytoma, IDH-mutant;oligodendroglioma, IDH-mutant and1p/19qcodeleted;glioblastoma, IDH-wildtype;other adult diffuse glioma NEC/ NOS). 2.For newly diagnosed patients, the patient has not received the first nonsurgical treatment. 3.For recurrent patients, the patient has not received the first non-surgical treatment after the recurrence. 4.No significant cognitive impairment based on researchers' judgment. 5.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. 6.Patients are undergoing anti-tumor treatment and continue to receive treatment within the next 28 days. 7.Patients sign written informed consent. 8.18 to 85 years old.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The customized PRO-CTCAE ;The Patient Global Impression of Change;

Secondary

MeasureTime frame
ClinRO CTCAE (Contains only the customized PRO-CTCAE scale's terms);The customized PRO-CTCAE (out-of-order version);QLQ-C30 ;KPS score;

Countries

China

Contacts

Public ContactWu Jinsong

Huashan Hospital, Fudan University

wjsongc@126.com+86 21 52887200

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026