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

1. september 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

350

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Latin American Cooperative Oncology Group

Etterforskere

  • Hovedetterforsker: Carolina Pêssoa, Instituto Nacional do Câncer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

24. august 2026

Først innsendt som oppfylte QC-kriteriene

24. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • LACOG 0425

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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