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

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.

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.

Time frame: Baseline

Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors

Time frame: 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.

Time frame: From date of diagnosis up to at least 30 months.

Percentage of participants alive and time from diagnosis to death from any cause.

Time frame: Up to 30 months.

Evaluation of objective tumor response to therapies assessed via central nervous system (CNS) imaging by investigator assessment.

Time frame: Up to 30 months.

Characterization of systemic therapies, radiation therapy details (dose, fractions), surgical procedures, and treatment sequencing.

Time frame: up to 30 months

Percentage of participants requiring dose reduction or treatment discontinuation and reasons for modification/discontinuation.

Time frame: Up to 30 months.

Time from the date of first systemic therapy initiation to the date of initiation of subsequent anticancer therapy.

Time frame: 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.

Time frame: 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.

Time frame: up to 30 months

Percentage of patients experiencing seizures for any reason at or during the initiation of the first systemic therapy.

Time frame: Baseline/up to 30 months

Functional status evaluated using the Karnofsky Performance Status scale (range 0-100%).

Time frame: up to 30 months

Assessment of KPS score decline/deterioration over time during the first systemic therapy.

Time frame: 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.

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)