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

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ClinicalTrials.gov Identifier: NCT05486923
Recruitment Status : Not yet recruiting
First Posted : August 4, 2022
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
Jinsong Wu, Huashan Hospital

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-word 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).


Condition or disease
Glioma Patient Reported Outcome Measures Self Report Adverse Effects

Detailed Description:

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-word 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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Estimated Study Start Date : September 17, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult-type diffuse gliomas patients in Chinese population [ Time Frame: June 1, 2024 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05486923


Contacts
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Contact: Jinsong Wu, Ph.D. & M.D. +86-21-52887200 wjsongc@126.com
Contact: Shuai Wu, Ph.D. & M.D. +86-21-52888771 wushuai0606@126.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Huashan Hospital
Investigators
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Study Chair: Jinsong Wu, Ph.D. & M.D. Huashan Hospital
Publications of Results:

Other Publications:
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Responsible Party: Jinsong Wu, Chief Physician, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT05486923    
Other Study ID Numbers: KY2022-681
First Posted: August 4, 2022    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jinsong Wu, Huashan Hospital:
Glioma
China
Patient Reported Outcome Measures
Self Report
Humans
Adverse effects
Adult
Surveys and Questionnaires
Research Design
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue