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
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.
Study Type
OBSERVATIONAL
Enrollment
350
IESG Instituto de Ensino da Saúde e Gestão
Salvador, Estado de Bahia, Brazil
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)
Salvador, Estado de Bahia, Brazil
Epidemiological profile of patients with IDH-mutant diffuse gliomas
Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors
Time frame: Baseline
Progression-Free Survival (PFS)
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.
Time frame: From date of diagnosis up to at least 30 months.
Overall Survival (OS)
Percentage of participants alive and time from diagnosis to death from any cause.
Time frame: From date of diagnosis up to at least 30 months.
Objective Response Rate (ORR)
Evaluation of objective tumor response to therapies assessed via central nervous system (CNS) imaging by investigator assessment.
Time frame: Up to 30 months.
Treatment Patterns and Sequencing
Characterization of systemic therapies, radiation therapy details (dose, fractions), surgical procedures, and treatment sequencing.
Time frame: Up to 30 months.
Dose Reduction and Discontinuation Rates
Percentage of participants requiring dose reduction or treatment discontinuation and reasons for modification/discontinuation.
Time frame: up to 30 months
Time to Next Intervention (TTNI)
Time from the date of first systemic therapy initiation to the date of initiation of subsequent anticancer therapy.
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ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
Salvador, Estado de Bahia, Brazil
OncoStar Rede D'or DF
Brasília, Federal District, Brazil
Oncocentro de Minas Gerais (Oncoclínicas)
Belo Horizonte, Minas Gerais, Brazil
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
Rio de Janeiro, Rio de Janeiro, Brazil
Futtura Oncologia - Hub de Pesquisa Clínica
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sírio-Libanês SP
São Paulo, São Paulo, Brazil
BP - A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
...and 2 more locations
Time frame: Up to 30 months.
Interval Between Last Surgery and First Systemic Therapy or Radiotherapy
Median interval in days/months between the date of the last glioma surgery and the initiation of the first systemic therapy or radiotherapy.
Time frame: Baseline/up to 30 months
Time From Initial Diagnosis to First Systemic or Radiotherapy Initiation
Time in days/months from the date of initial pathological diagnosis to the start of first systemic therapy or radiotherapy.
Time frame: Baseline/up to 30 months
Prevalence of Seizures at First Systemic Therapy
Percentage of patients experiencing seizures for any reason at or during the initiation of the first systemic therapy.
Time frame: up to 30 months
Karnofsky Performance Status (KPS) Score
Functional status evaluated using the Karnofsky Performance Status scale (range 0-100%).
Time frame: Baseline/up to 30 months
Karnofsky Performance Status (KPS) Deterioration
Assessment of KPS score decline/deterioration over time during the first systemic therapy.
Time frame: up to 30 months
Frequency and Results of Molecular Testing
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.
Time frame: Baseline