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

1 de septiembre de 2026 actualizado 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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 estudio

De observación

Inscripción (Estimado)

350

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Project Manager
  • Número de teléfono: +55 (51) 3384.5334
  • Correo electrónico: lacog0425@lacog.group

Ubicaciones de estudio

  • 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
        • Contacto:
          • Número de teléfono: +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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Epidemiological profile of patients with IDH-mutant diffuse gliomas
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Latin American Cooperative Oncology Group

Investigadores

  • Investigador principal: Carolina Pêssoa, Instituto Nacional do Câncer

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

24 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de agosto de 2026

Publicado por primera vez (Actual)

27 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • LACOG 0425

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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