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

2026년 9월 1일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

350

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Laura Voelcker
전화번호: +55 (51) 3384.5334
이메일: laura.voelcker@lacog.group

연구 연락처 백업

이름: Project Manager
전화번호: +55 (51) 3384.5334
이메일: lacog0425@lacog.group

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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고령자

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아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Epidemiological profile of patients with IDH-mutant diffuse gliomas 기간: Baseline	Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors	Baseline

2차 결과 측정

결과 측정	측정값 설명	기간
Progression-Free Survival (PFS) 기간: 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) 기간: 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) 기간: 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 기간: 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 기간: 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) 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Latin American Cooperative Oncology Group

수사관

수석 연구원: Carolina Pêssoa, Instituto Nacional do Câncer

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 3월 1일

연구 완료 (추정된)

2028년 5월 1일

연구 등록 날짜

최초 제출

2026년 8월 24일

QC 기준을 충족하는 최초 제출