Clinical trial · Observational
Epidemiological Profile of Patients With IDH-Mutant Diffuse Gliomas Diagnosed From 2021 in Brazil
A Single-arm Observational Study to Characterize the Epidemiological Profile of Patients With IDH-mutant Diffuse Gliomas Diagnosed From 2021 in Brazil - BRIGHT Study (LACOG 0425)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Glioma | Diffuse Glioma | ONTOLOGY_EXACT | 0.98 |
| IDH-mutant Gliomas | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- IDH-mutant diffuse glioma cohort
- description
- Male or female patients aged 12 years or older histologically confirmed diagnosis of diffuse glioma from 2021 and confirmed IDH mutation identified by IHC or PCR/NGS.
Primary outcomes (1)
- measure
- Epidemiological profile of patients with IDH-mutant diffuse gliomas
- timeFrame
- Baseline
- description
- Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors
Secondary outcomes (12)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From date of diagnosis up to at least 30 months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: Since the study is observational, there are no extensive Exclusion Criteria, but the following criteria excludes patients from the study to ensure data collected by be analyzed from a broader context and compared to other studies of this kind: * 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.
References
Publications (0)
Data not yet available