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

NCT05486923 | Completed DMC

• 1 other identifier: KY2022-681
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 14

Brief Summary

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).

Conditions

Glioma; Patient Reported Outcome Measures; Self Report; Adverse Effects

Keywords

Glioma; China; Patient Reported Outcome Measures; Self Report; Humans; Adverse effects; Adult; Surveys and Questionnaires; Research Design

Outcome Measures

Primary Outcomes (1)

• 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.

  December 1, 2025

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• For newly diagnosed patients, the patient has not received the first non-surgical treatment.
• For recurrent patients, the patient has not received the first non-surgical treatment after the recurrence.
• to 85 years old.
• No significant cognitive impairment based on researchers' judgment.
• 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.
• Patients are undergoing anti-tumor treatment and continue to receive treatment within the next 28 days.
• Patients sign written informed consent.

You may not qualify if:

• Patients who are not considered suitable for this study.
• Since the diagnosis, the patient has undergone non-surgical treatment.
• Patients fail to complete the questionnaire within 42 days of signing informed consent.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (14)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Xuan Wu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Guangdong Sanjiu Brain Hospital

Guangzhou, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

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

Wuhan, Hubei, China

Location

Jiangsu People's Hospital

Nanjing, Jiangsu, China

Location

Xijing Hospital

Xi'an, Shaanxi, China

Location

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

Shanghai, Shanghai Municipality, 200040, China

Location

Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

East Hospital Affiliated To Tongji University

Shanghai, Shanghai Municipality, China

Location

Shanghai Proton and Heavy Ion Hospital

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

Related Publications (11)

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• Armstrong TS, Wefel JS, Wang M, Gilbert MR, Won M, Bottomley A, Mendoza TR, Coens C, Werner-Wasik M, Brachman DG, Choucair AK, Mehta M. Net clinical benefit analysis of radiation therapy oncology group 0525: a phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma. J Clin Oncol. 2013 Nov 10;31(32):4076-84. doi: 10.1200/JCO.2013.49.6067. Epub 2013 Oct 7.

  PMID: 24101048 BACKGROUND

• Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.

  PMID: 24552317 BACKGROUND

• Armstrong TS, Bishof AM, Brown PD, Klein M, Taphoorn MJ, Theodore-Oklota C. Determining priority signs and symptoms for use as clinical outcomes assessments in trials including patients with malignant gliomas: Panel 1 Report. Neuro Oncol. 2016 Mar;18 Suppl 2(Suppl 2):ii1-ii12. doi: 10.1093/neuonc/nov267.

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• Yeung AR, Pugh SL, Klopp AH, Gil KM, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Bruner DW, Kachnic LA. Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study. J Clin Oncol. 2020 May 20;38(15):1685-1692. doi: 10.1200/JCO.19.02381. Epub 2020 Feb 19.

  PMID: 32073955 BACKGROUND

• Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.

  PMID: 26644527 BACKGROUND

• Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014 Sep 29;106(9):dju244. doi: 10.1093/jnci/dju244. Print 2014 Sep.

  PMID: 25265940 BACKGROUND

• Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson TM, Bennett AV, Denicoff AM, O'Mara AM, Li Y, Clauser SB, Bryant DM, Bearden JD 3rd, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E; National Cancer Institute PRO-CTCAE Study Group. Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 2015 Nov;1(8):1051-9. doi: 10.1001/jamaoncol.2015.2639.

  PMID: 26270597 BACKGROUND

• Trask PC, Dueck AC, Piault E, Campbell A. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials. Clin Trials. 2018 Dec;15(6):616-623. doi: 10.1177/1740774518799985. Epub 2018 Sep 19.

  PMID: 30230365 BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jinsong Wu, Ph.D. & M.D.

  Huashan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 4, 2022
• Study Start: September 19, 2022
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)