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

1. september 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

350

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Epidemiological profile of patients with IDH-mutant diffuse gliomas
Tidsramme: Baseline
Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Latin American Cooperative Oncology Group

Efterforskere

  • Ledende efterforsker: Carolina Pêssoa, Instituto Nacional do Câncer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

24. august 2026

Først indsendt, der opfyldte QC-kriterier

24. august 2026

Først opslået (Faktiske)

27. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • LACOG 0425

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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