Diffuse GliomaBRIGHTNCT07789678
Epidemiological Profile of Patients With IDH-Mutant Diffuse Gliomas Diagnosed From 2021 in Brazil
An observational study of Diffuse Glioma and IDH-mutant Gliomas, run by Latin American Cooperative Oncology Group at 12 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Diffuse Glioma, IDH-mutant Gliomas
- How many people
- 350 participants
- Where
- 12 sitesBrazil
- Study dates
- Sep 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female patients (aged 12 years or older), able to provide informed consent, diagnosed with IDH-mutant diffuse glioma in Brazil from 2021.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Brazil12 sites
Oncocentro de Minas Gerais (Oncoclínicas)
Belo Horizonte, Minas Gerais, 30360-680
Flávio Brandão
OncoStar Rede D'or DF
Brasília, Federal District, 70390-140
Daniel Marques
Futtura Oncologia - Hub de Pesquisa Clínica
Porto Alegre, Rio Grande do Sul, 90470-340
Luisa Fasolo
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, 20230-130
+5521991169827
Carolina Pessôa
Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
Rio de Janeiro, Rio de Janeiro, 22793-080
Victor Teixeira
IESG Instituto de Ensino da Saúde e Gestão
Salvador, Estado de Bahia, 40050-050
Teresa Fonseca
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)
Salvador, Estado de Bahia, 40050-410
Daniela Oliveira
ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
Salvador, Estado de Bahia, 41950-640
Aknar Calabrich
Hospital Sírio-Libanês SP
São Paulo, São Paulo, 01308-050
Marcos Maldaun
BP - A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, 01323-030
Camilla Yamada
GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer
São Paulo, São Paulo, 04039-001
Andrea Cappellano
HIAE - Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05653-000
Suzana Malheiros
About this study
Official title: 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
Read the 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.
- Conditions
- Diffuse Glioma, IDH-mutant Gliomas
- Keywords
- IDH-mutant diffuse glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: Up to 30 months.
Treatment Patterns and Sequencing
Characterization of systemic therapies, radiation therapy details (dose, fractions), surgical procedures, and treatment sequencing.
Measured: Up to 30 months.
Dose Reduction and Discontinuation Rates
Percentage of participants requiring dose reduction or treatment discontinuation and reasons for modification/discontinuation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 30 months
Karnofsky Performance Status (KPS) Score
Functional status evaluated using the Karnofsky Performance Status scale (range 0-100%).
Measured: Baseline/up to 30 months
Karnofsky Performance Status (KPS) Deterioration
Assessment of KPS score decline/deterioration over time during the first systemic therapy.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Pêssoa, Principal investigator, Instituto Nacional do Câncer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789678
- Sponsor's protocol ID
- LACOG 0425
- Acronym
- BRIGHT
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07789678
- Acronym / sponsor ID
- BRIGHT / LACOG 0425
- Conditions
- Diffuse Glioma, IDH-mutant Gliomas
- Keywords
- IDH-mutant diffuse glioma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female patients (aged 12 years or older), able to provide informed consent, diagnosed with IDH-mutant diffuse glioma in Brazil from 2021.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiological profile of patients with IDH-mutant diffuse gliomas
Time frame: Baseline
Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors
12 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From date of diagnosis up to at least 30 months.
Overall Survival (OS)
Time frame: From date of diagnosis up to at least 30 months.
Objective Response Rate (ORR)
Time frame: Up to 30 months.
Treatment Patterns and Sequencing
Time frame: Up to 30 months.
Dose Reduction and Discontinuation Rates
Time frame: up to 30 months
Time to Next Intervention (TTNI)
Time frame: Up to 30 months.
Interval Between Last Surgery and First Systemic Therapy or Radiotherapy
Time frame: Baseline/up to 30 months
Time From Initial Diagnosis to First Systemic or Radiotherapy Initiation
Time frame: Baseline/up to 30 months
Prevalence of Seizures at First Systemic Therapy
Time frame: up to 30 months
Karnofsky Performance Status (KPS) Score
Time frame: Baseline/up to 30 months
Karnofsky Performance Status (KPS) Deterioration
Time frame: up to 30 months
Frequency and Results of Molecular Testing
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolina Pêssoa principal investigator
Instituto Nacional do Câncer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Glioma and IDH-mutant Gliomas, run by Latin American Cooperative Oncology Group at 12 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+55 (51) 3384.5334, lacog0425@lacog.group), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological profile of patients with IDH-mutant diffuse gliomas (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.