A Single-arm Observational Study to Characterize the Epidemiological Profile of Patients With IDH-mutant Diffuse Gliomas Diagnosed From 2021 in Brazil. (BRIGHT)

August 24, 2026 updated by: Latin American Cooperative Oncology Group

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).

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This study is designed to describe the epidemiological, anti-cancer treatment and clinical outcomes of patients with IDH-mutant diffuse glioma in Brazil. Patients ≥ 12 years old diagnosed with IDH-mutant diffuse gliomas from 2021 will be included. In the baseline medical chart evaluation, data on epidemiology, pathological, treatment patterns, toxicities, and clinical outcomes will be collected. LACOG (Sponsor) will be responsible for managing data from this study, including quality verification. Manually entered data will be captured via EDC using eCRFs. The EDC system used in this study will be REDCap (Research Electronic Data Capture) - that meets the established standards approved for the safety of health information and is validated. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for continuous data downloads for common statistical packages; and 4) procedures for data integration and interoperability with external sources. The system also meets ICH guidelines on electronic handling of study data and will be available for audit upon request. Patient confidentiality will be strictly maintained.

An informed consent form will be offered to all living patients. The consent will be unnecessary in patients that could not be reached or that have passed away (died) as per regulation Res. CNS 466/12 item IV.8. Consent will be obtained from legal guardians for patients between the ages of 12 and 17 years old as per Brazilian regulation.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40050-050
        • IESG Instituto de Ensino da Saúde e Gestão
        • Principal Investigator:
          • Teresa Fonseca
      • Salvador, Estado de Bahia, Brazil, 40050-410
        • Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)
        • Principal Investigator:
          • Daniela Oliveira
      • Salvador, Estado de Bahia, Brazil, 41950-640
        • ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
        • Principal Investigator:
          • Aknar Calabrich
    • Federal District
      • Brasília, Federal District, Brazil, 70390-140
        • OncoStar Rede D'or DF
        • Principal Investigator:
          • Daniel Marques
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30360-680
        • Oncocentro de Minas Gerais (Oncoclínicas)
        • Principal Investigator:
          • Flávio Brandão
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90470-340
        • Futtura Oncologia - Hub de Pesquisa Clínica
        • Principal Investigator:
          • Luisa Fasolo
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20230-130
        • INCA - Instituto Nacional de Câncer
        • Contact:
          • Phone Number: +5521991169827
        • Principal Investigator:
          • Carolina Pessôa
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22793-080
        • Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
        • Principal Investigator:
          • Victor Teixeira
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05653-000
        • HIAE - Hospital Israelita Albert Einstein
        • Principal Investigator:
          • Suzana Malheiros
      • São Paulo, São Paulo, Brazil, 01308-050
        • Hospital Sírio-Libanês SP
        • Principal Investigator:
          • Marcos Maldaun
      • São Paulo, São Paulo, Brazil, 01323-030
        • BP - A Beneficência Portuguesa de São Paulo
        • Principal Investigator:
          • Camilla Yamada
      • São Paulo, São Paulo, Brazil, 04039-001
        • GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer
        • Principal Investigator:
          • Andrea Cappellano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
IDH-mutant diffuse glioma cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological profile of patients with IDH-mutant diffuse gliomas
Time Frame: Baseline
Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From date of diagnosis up to at least 30 months.
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.
From date of diagnosis up to at least 30 months.
Overall Survival (OS)
Time Frame: From date of diagnosis up to at least 30 months.
Percentage of participants alive and time from diagnosis to death from any cause.
From date of diagnosis up to at least 30 months.
Objective Response Rate (ORR)
Time Frame: Up to 30 months.
Evaluation of objective tumor response to therapies assessed via central nervous system (CNS) imaging by investigator assessment.
Up to 30 months.
Treatment Patterns and Sequencing
Time Frame: Up to 30 months.
Characterization of systemic therapies, radiation therapy details (dose, fractions), surgical procedures, and treatment sequencing.
Up to 30 months.
Dose Reduction and Discontinuation Rates
Time Frame: up to 30 months
Percentage of participants requiring dose reduction or treatment discontinuation and reasons for modification/discontinuation.
up to 30 months
Time to Next Intervention (TTNI)
Time Frame: Up to 30 months.
Time from the date of first systemic therapy initiation to the date of initiation of subsequent anticancer therapy.
Up to 30 months.
Interval Between Last Surgery and First Systemic Therapy or Radiotherapy
Time Frame: Baseline/up to 30 months
Median interval in days/months between the date of the last glioma surgery and the initiation of the first systemic therapy or radiotherapy.
Baseline/up to 30 months
Time From Initial Diagnosis to First Systemic or Radiotherapy Initiation
Time Frame: Baseline/up to 30 months
Time in days/months from the date of initial pathological diagnosis to the start of first systemic therapy or radiotherapy.
Baseline/up to 30 months
Prevalence of Seizures at First Systemic Therapy
Time Frame: up to 30 months
Percentage of patients experiencing seizures for any reason at or during the initiation of the first systemic therapy.
up to 30 months
Karnofsky Performance Status (KPS) Score
Time Frame: Baseline/up to 30 months
Functional status evaluated using the Karnofsky Performance Status scale (range 0-100%).
Baseline/up to 30 months
Karnofsky Performance Status (KPS) Deterioration
Time Frame: up to 30 months
Assessment of KPS score decline/deterioration over time during the first systemic therapy.
up to 30 months
Frequency and Results of Molecular Testing
Time Frame: Baseline
Description of the proportion and specific results of molecular testing (e.g., IDH mutation testing by IHC or PCR/NGS, 1p/19q codeletion, CDKN2A/B) performed in routine clinical practice in Brazil.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

Investigators

  • Principal Investigator: Carolina Pêssoa, Instituto Nacional do Câncer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LACOG 0425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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