Epidemiological Profile of Patients With IDH-Mutant Diffuse Gliomas Diagnosed From 2021 in Brazil
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorLatin American Cooperative Oncology Group
About this trial
This is a real-world, retrospective, non-interventional, single-arm, multi-center Brazilian study that will include patients diagnosed with IDH-mutant diffuse glioma in Brazil from 2021. Eligible patients will be included in this study to have their medical charts data collected by site personnel. Included patients won´t be requested to attend protocol-specific visits and treatment decisions and disease management will be at the investigator's discretion
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients (aged 12 years or older);
Histologically confirmed diagnosis of diffuse glioma from 2021;
Confirmed IDH mutation identified by IHC or PCR/NGS;
Willing and able to provide written informed consent, applicable to living patients. In case of patients <18 years of age, their legal guardians should provide an written informed consent
Disqualifiers
Patients without medical record available (lost, empty or irretrievable clinical information).
Living patients and/or legal guardians of patients <18 years of age who did not accept or withdrew their consent from the study.
Trial population
Male or female patients (aged 12 years or older), able to provide informed consent, diagnosed with IDH-mutant diffuse glioma in Brazil from 2021.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
350 Participants
are grouped into 1 trial groupGroup A: IDH-mutant diffuse glioma cohort
Trial outcomes
Primary outcomes
1
Epidemiological profile of patients with IDH-mutant diffuse gliomas
Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors
Time frame
BaselineSecondary outcomes
1
Progression-Free Survival (PFS)
Date of initial diagnosis/treatment to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed via CNS imaging per investigator assessment.
Time frame
From date of diagnosis up to at least 30 months.2
Overall Survival (OS)
Percentage of participants alive and time from diagnosis to death from any cause.
Time frame
From date of diagnosis up to at least 30 months.3
Objective Response Rate (ORR)
Evaluation of objective tumor response to therapies assessed via central nervous system (CNS) imaging by investigator assessment.
Time frame
Up to 30 months.4
Treatment Patterns and Sequencing
Characterization of systemic therapies, radiation therapy details (dose, fractions), surgical procedures, and treatment sequencing.
Time frame
Up to 30 months.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: