An observational study in Diffuse Glioma and IDH-mutant Gliomas, sponsored by Latin American Cooperative Oncology Group. Recruiting at 12 sites in Brazil. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Latin American Cooperative Oncology Group · Observational
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.
Latin American Cooperative Oncology Group is the lead sponsor of 48 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male or female patients (aged 12 years or older), able to provide informed consent, diagnosed with IDH-mutant diffuse glioma in Brazil from 2021.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Feb 2027, 0 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: start Sep 2026 → Feb 2027, primary completion Mar 2027 → Feb 2027 and completion May 2028 → Feb 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Latin American Cooperative Oncology Group