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

2026年9月1日更新者：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

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

350

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Laura Voelcker
電話番号：+55 (51) 3384.5334
メール：laura.voelcker@lacog.group

研究連絡先のバックアップ

名前：Project Manager
電話番号：+55 (51) 3384.5334
メール：lacog0425@lacog.group

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

子
大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Epidemiological profile of patients with IDH-mutant diffuse gliomas 時間枠：Baseline	Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors	Baseline

二次結果の測定

結果測定	メジャーの説明	時間枠
Progression-Free Survival (PFS) 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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 時間枠：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) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Latin American Cooperative Oncology Group

捜査官

主任研究者：Carolina Pêssoa、Instituto Nacional do Câncer

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2028年5月1日

試験登録日

最初に提出

2026年8月24日

QC基準を満たした最初の提出物