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

1 września 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

350

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Laura Voelcker
Numer telefonu: +55 (51) 3384.5334
E-mail: laura.voelcker@lacog.group

Kopia zapasowa kontaktu do badania

Nazwa: Project Manager
Numer telefonu: +55 (51) 3384.5334
E-mail: lacog0425@lacog.group

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dziecko
Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Epidemiological profile of patients with IDH-mutant diffuse gliomas Ramy czasowe: Baseline	Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors	Baseline

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Progression-Free Survival (PFS) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Latin American Cooperative Oncology Group

Śledczy

Główny śledczy: Carolina Pêssoa, Instituto Nacional do Câncer

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

24 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości