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Epidemiological Profile of Patients With IDH-Mutant Diffuse Gliomas Diagnosed From 2021 in Brazil (BRIGHT)

1 de setembro de 2026 atualizado por: 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

350

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Laura Voelcker
Número de telefone: +55 (51) 3384.5334
E-mail: laura.voelcker@lacog.group

Estude backup de contato

Nome: Project Manager
Número de telefone: +55 (51) 3384.5334
E-mail: lacog0425@lacog.group

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Filho
Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Male or female patients (aged 12 years or older), able to provide informed consent, diagnosed with IDH-mutant diffuse glioma in Brazil from 2021.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Epidemiological profile of patients with IDH-mutant diffuse gliomas Prazo: Baseline	Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors	Baseline

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Progression-Free Survival (PFS) Prazo: 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) Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Latin American Cooperative Oncology Group

Investigadores

Investigador principal: Carolina Pêssoa, Instituto Nacional do Câncer

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de maio de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ