NCT07789678

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2026

Geographic Reach
1 country

12 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Diffuse GliomaIDH-mutant Gliomas

Keywords

IDH-mutant diffuse glioma

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (12)

  • Progression-Free Survival (PFS)

    From date of diagnosis up to at least 30 months.

  • Overall Survival (OS)

    From date of diagnosis up to at least 30 months.

  • Objective Response Rate (ORR)

    Up to 30 months.

  • Treatment Patterns and Sequencing

    Up to 30 months.

  • Dose Reduction and Discontinuation Rates

    up to 30 months

  • +7 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

IESG Instituto de Ensino da Saúde e Gestão

Salvador, Estado de Bahia, 40050-050, Brazil

Location

Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)

Salvador, Estado de Bahia, 40050-410, Brazil

Location

ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia

Salvador, Estado de Bahia, 41950-640, Brazil

Location

OncoStar Rede D'or DF

Brasília, Federal District, 70390-140, Brazil

Location

Oncocentro de Minas Gerais (Oncoclínicas)

Belo Horizonte, Minas Gerais, 30360-680, Brazil

Location

INCA - Instituto Nacional de Câncer

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

Location

Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)

Rio de Janeiro, Rio de Janeiro, 22793-080, Brazil

Location

Futtura Oncologia - Hub de Pesquisa Clínica

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

Location

Hospital Sírio-Libanês SP

São Paulo, São Paulo, 01308-050, Brazil

Location

BP - A Beneficência Portuguesa de São Paulo

São Paulo, São Paulo, 01323-030, Brazil

Location

GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer

São Paulo, São Paulo, 04039-001, Brazil

Location

HIAE - Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05653-000, Brazil

Location

Study Officials

  • Carolina Pêssoa

    Instituto Nacional do Câncer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

+55 (51) 3384.5334lacog0425@lacog.group

Laura Voelcker

CONTACT

+55 (51) 3384.5334laura.voelcker@lacog.group

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(12)