Diffuse Glioma, IDH-mutant Gliomas
Conditions
Keywords
IDH-mutant diffuse glioma
Brief summary
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
Detailed description
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.
Interventions
None listed
Sponsors
Latin American Cooperative Oncology Group
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epidemiological profile of patients with IDH-mutant diffuse gliomas | Baseline | Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 30 months. | Evaluation of objective tumor response to therapies assessed via central nervous system (CNS) imaging by investigator assessment. |
| Treatment Patterns and Sequencing | Up to 30 months. | Characterization of systemic therapies, radiation therapy details (dose, fractions), surgical procedures, and treatment sequencing. |
| Dose Reduction and Discontinuation Rates | up to 30 months | Percentage of participants requiring dose reduction or treatment discontinuation and reasons for modification/discontinuation. |
| Time to Next Intervention (TTNI) | Up to 30 months. | Time from the date of first systemic therapy initiation to the date of initiation of subsequent anticancer therapy. |
| Interval Between Last Surgery and First Systemic Therapy or Radiotherapy | 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 From Initial Diagnosis to First Systemic or Radiotherapy Initiation | 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. |
| Prevalence of Seizures at First Systemic Therapy | up to 30 months | Percentage of patients experiencing seizures for any reason at or during the initiation of the first systemic therapy. |
| Karnofsky Performance Status (KPS) Score | Baseline/up to 30 months | Functional status evaluated using the Karnofsky Performance Status scale (range 0-100%). |
| Karnofsky Performance Status (KPS) Deterioration | up to 30 months | Assessment of KPS score decline/deterioration over time during the first systemic therapy. |
| Frequency and Results of Molecular Testing | 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. |
| Overall Survival (OS) | From date of diagnosis up to at least 30 months. | Percentage of participants alive and time from diagnosis to death from any cause. |
| Progression-Free Survival (PFS) | 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. |
Countries
Brazil
Contacts
CONTACTProject Manager
CONTACTLaura Voelcker
PRINCIPAL_INVESTIGATORCarolina Pêssoa
Instituto Nacional do Câncer
Outcome results
None listed