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

1 settembre 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

350

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Laura Voelcker
Numero di telefono: +55 (51) 3384.5334
Email: laura.voelcker@lacog.group

Backup dei contatti dello studio

Nome: Project Manager
Numero di telefono: +55 (51) 3384.5334
Email: lacog0425@lacog.group

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Bambino
Adulto
Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Epidemiological profile of patients with IDH-mutant diffuse gliomas Lasso di tempo: Baseline	Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors	Baseline

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Progression-Free Survival (PFS) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Latin American Cooperative Oncology Group

Investigatori

Investigatore principale: Carolina Pêssoa, Instituto Nacional do Câncer

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

24 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità