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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 85 Years
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05486923
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Huashan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jinsong Wu, Ph.D. & M.D.
Principal Investigator Affiliation Huashan Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma, Patient Reported Outcome Measures, Self Report, Adverse Effects
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing,

Site Contact

Xiaoguang Qiu

wjsongc@126.com

+86-21-52887200

Tsinghua Changgung Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Tsinghua Changgung Hospital

Beijing, Beijing,

Site Contact

Wei Zhang

wjsongc@126.com

+86-21-52887200

Beijing, Beijing, China

Status

Recruiting

Address

Xuan Wu Hospital, Capital Medical University

Beijing, Beijing,

Site Contact

Geng Xu

wjsongc@126.com

+86-21-52887200

Chongqing, Chongqing, China

Status

Recruiting

Address

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing,

Site Contact

Xiaochuan Sun

wjsongc@126.com

+86-21-52887200

Fuzhou, Fujian, China

Status

Recruiting

Address

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian,

Site Contact

Zanyi Wu

wjsongc@126.com

+86-21-52887200

Guangdong Sanjiu Brain Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Guangdong Sanjiu Brain Hospital

Guangzhou, Guangdong,

Site Contact

Linbo Cai

wjsongc@126.com

+86-21-52887200

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong,

Site Contact

Yonggao Mou

wjsongc@126.com

+86-21-52887200

Wuhan, Hubei, China

Status

Recruiting

Address

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei,

Site Contact

Kai Shu

wjsongc@126.com

+86-21-52887200

Jiangsu People's Hospital, Nanjing, Jiangsu, China

Status

Recruiting

Address

Jiangsu People's Hospital

Nanjing, Jiangsu,

Site Contact

Yongping You

wjsongc@126.com

+86-21-52887200

Yinchuan, Ningxia, China

Status

Recruiting

Address

The General Hospital of Ningxia Medical University

Yinchuan, Ningxia,

Site Contact

Hui Ma

wjsongc@126.com

+86-21-52887200

Xijing Hospital, Xi'an, Shaanxi, China

Status

Recruiting

Address

Xijing Hospital

Xi'an, Shaanxi,

Site Contact

Zhou Fei

wjsongc@126.com

+86-21-52887200

Shanghai, Shanghai, China

Status

Recruiting

Address

Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University

Shanghai, Shanghai, 200040

Site Contact

Jinsong Wu, Ph.D. & M.D.

wjsongc@126.com

+86-21-52887200

Changhai Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Changhai Hospital

Shanghai, Shanghai,

Site Contact

Juxiang Kong

wjsongc@126.com

+86-21-52887200

Shanghai, Shanghai, China

Status

Recruiting

Address

East Hospital Affiliated To Tongji University

Shanghai, Shanghai,

Site Contact

Chunlong Zhong

wjsongc@126.com

+86-21-52887200

Shanghai Proton and Heavy Ion Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Proton and Heavy Ion Hospital

Shanghai, Shanghai,

Site Contact

Lin Kong

wjsongc@126.com

+86-21-52887200

Kunming, Yunnan, China

Status

Recruiting

Address

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan,

Site Contact

Zhiwei Tang

wjsongc@126.com

+86-21-52887200

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang,

Site Contact

Jianmin Zhang

wjsongc@126.com

+86-21-52887200

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