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Low-grade Gliomas in Argentina: Incidence, Survival, and Therapeutic Strategies

1 de junho de 2026 atualizado por: Ivan A. Huespe, Hospital Italiano de Buenos Aires

Low-grade gliomas (LGG) are slow-growing primary brain tumors (WHO grades I-II), and their incidence, survival, and treatment patterns in middle-income settings such as Argentina remain poorly characterized. This retrospective, multicenter study comprises two complementary cohorts:

  1. Cohort 1: The "captive" population covered under the Hospital Italiano de Buenos Aires Health Plan (January 2011-December 2023) to estimate LGG incidence density.
  2. Cohort 2: Histologically confirmed LGG patients treated at the major referral centers to describe overall survival (OS) and disease-free survival (DFS) at 1 and 5 years.

Demographic, clinical, pathological, and treatment data will be collected in a centralized REDCap database.

The primary objective is to describe LGG incidence in Argentina and estimate survival using Kaplan-Meier curves. The secondary objectives include characterizing therapeutic strategies, molecular mutations, and prognostic factors through Cox regression analysis. This registry will fill a critical gap in LGG epidemiology in middle-income countries and generate hypotheses for future research.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

Background Low-grade gliomas (LGG) represent approximately 6% of primary central nervous system tumors in adults and exhibit unpredictable biological behavior. Although high-income countries have published LGG incidence and survival data stratified by age, sex, and molecular profile, data from Argentina and other middle-income regions are scarce. IDH mutations and other molecular markers, along with clinical factors (age, seizures, tumor volume, and location) and treatment modalities, influence disease progression and prognosis in these patients.

Objectives

  • Primary (Cohort 1): Estimate LGG incidence density in the Hospital Italiano Health Plan population (2011-2023), expressed as cases per 100,000 person-years.
  • Primary (Cohort 2): Describe OS and DFS at 1 and 5 years post-diagnosis.
  • Secondary: Characterize therapeutic strategies (surgical, chemoradiotherapy, monotherapy), molecular profile (IDH, P53, 1p/19q mutations), and identify prognostic factors associated with OS and DFS using multivariable Cox regression.

Design and Scope

This is a retrospective, multicenter, observational cohort study with two cohorts:

  • Cohort 1 (incidence): Retrospective analysis of the Hospital Italiano de Buenos Aires database to identify new LGG cases from January 2011 to December 2023.
  • Cohort 2 (survival): Consecutive inclusion of all patients with histologically confirmed LGG treated at the participating centers during the same period.

Population

  • Inclusion (Cohort 1): Age ≥ 18 years, HIBA affiliates, ≥ 1 year of documented follow-up.
  • Inclusion (Cohort 2): Age ≥ 18 years, histologically confirmed LGG (WHO I-II), ≥ 1 year of documented follow-up.
  • Exclusion (both cohorts): Incomplete or uncertain diagnosis per histopathological/genetic criteria.

Data Collection & Management Local investigators will extract demographic, clinical, radiological, pathological, and treatment data from electronic health records. All data will be entered retrospectively into a secure, centralized REDCap database with individual user credentials. Quality control checks (cross-validation with source records) will be performed periodically. After analysis and publication, the database will be permanently deleted to preserve confidentiality.

Key Variables

  • Demographics: age, sex, comorbidities, functional status, care setting.
  • Tumor Characteristics: volume, location (supra-/infratentorial, hemisphere), histology, IDH/P53 mutation status.
  • Treatment Details: extent of resection (total/partial), chemotherapy (agents, cycles, toxicities), radiotherapy (type, dose, fractions).
  • Outcomes: time to progression, OS, DFS, postoperative complications, adverse events.

Statistical Analysis

  • Cohort 1: Calculate incidence density (cases/person-years) with 95 % confidence intervals by age and sex. Standardization will use INDEC population data.
  • Cohort 2: Estimate OS and DFS at 1, and 5 years using Kaplan-Meier methods; report proportions with 95 % CIs. Perform multivariable Cox regression to identify prognostic factors (age, tumor volume, mutation status, treatment type), reporting hazard ratios with 95 % CIs.
  • Sample Size: Approximately 180 000 person-years in Cohort 1 (projected 13-14 LGG cases); ≥ 40 patients in Cohort 2 to estimate a 30 % survival rate with ± 10 % precision.

Ethical Considerations The study has a waiver of informed consent under local regulations and CIOMS guidelines. All data will be anonymized using numeric codes and stored on encrypted servers until study completion. In addition, each participating center must obtain approval from its respective ethics committee (IRB/EC) before initiating data collection and provide documentation of such approvals.

Tipo de estudo

Observacional

Inscrição (Estimado)

40

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Argentina
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
        • Recrutamento
        • Hospital Aleman
        • Contato:
      • Buenos Aires, Buenos Aires F.D., Argentina, C1199ABB
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5016KEH
        • Recrutamento
        • Hospital Privado Universitario de Córdoba
        • Contato:
    • Florencio Varela
      • Buenos Aires, Florencio Varela, Argentina, B1888
        • Recrutamento
        • Hospital de Alta Complejidad El Cruce - Dr. Néstor Kirchner
        • Contato:
    • Pilar
      • Buenos Aires, Pilar, Argentina, B1629AHJ
        • Recrutamento
        • Hospital Universitario Austral
        • Contato:
    • San Justo
      • Buenos Aires, San Justo, Argentina, C1198AAW

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult (≥18 years) Hospital Italiano Health Plan affiliates (Cohort 1) and histologically confirmed WHO grade I-II low-grade glioma patients treated at participating centers (Cohort 2), retrospectively identified for incidence and survival analyses.

Descrição

Study population cohort 1

  • Inclusion Criteria

    • Adult patients (≥18 years old) affiliated to the health plan of Hospital Italiano de Buenos Aires.
    • Documented clinical follow-up of at least 1 year during the study period.

  • Exclusion Criteria

    • Patients not affiliated to the health plan of the Hospital Italiano de Buenos Aires.

Study population cohort 2

  • Inclusion Criteria

    • Adult patients (≥18 years) with histopathologically confirmed diagnosis of low-grade glioma (WHO grades I and II).

  • Exclusion Criteria

    • Incomplete or doubtful diagnosis based on histopathologic and molecular criteria.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Cohort 1: Incidence cohort
Affiliates of the Hospital Italiano Health Plan from January 2011 to December 2023 used to estimate the incidence density of low-grade gliomas.
Cohort 2: Survival cohort
Histologically confirmed low-grade glioma patients treated at participating centers, followed retrospectively for up to 5 years to assess overall and disease-free survival.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Describe the incidence density of LGG
Prazo: January 2011 - December 2023
The incidence density will be estimated as the number of new cases of LGG divided by the person-time at risk (expressed in patient-years). The incidence stratified by age group, and sex, with corresponding 95% confidence intervals, will be described.
January 2011 - December 2023
Generate an Argentine population projection model
Prazo: January 2011 - December 2023
A model will be developed to extrapolate the incidence rates of LGG calculated in the HIBA cohort to the general Argentine population. Initially, specific incidence rates will be estimated, both overall and stratified by age and sex, including 95% confidence intervals to ensure accuracy. Subsequently, a standardization process will be applied to adjust for demographic differences between the HIBA population and the general population of Argentina, using data from the National Institute of Statistics and Census of Argentina (In Spanish: Instituto Nacional de Estadísticas y Censos [INDEC]). Finally, the expected cases of LGG will be extrapolated to the national level, generating specific estimates by age and sex per year.
January 2011 - December 2023
Describe overall survival (OS) and disease-free survival (DFS)
Prazo: Up to 5 years post-diagnosis
OS and DFS will be estimated using life tables and plotted with Kaplan-Meier graphs. Survival and disease-free survival at 1 and 5 years will be reported with the corresponding proportion and 95% confidence interval.
Up to 5 years post-diagnosis
Describe the treatment strategies implemented in patients with LGG in public and private institutions
Prazo: January 2011 - December 2023
Absolute and relative frequencies will be calculated for the treatment strategies used (surgical treatment, chemo-radiotherapy, radiotherapy alone), stratified by type of institution (public or private). Proportions will be reported with their corresponding 95% confidence interval.
January 2011 - December 2023

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Evaluate factors associated with shorter time to death or death and relapse
Prazo: Up to 5 years post-diagnosis
Cox regression models will be used to identify factors associated with shorter time to death and time to death or relapse. Independent variables such as age, comorbidities, tumor location and volume, molecular status (HDI, 1p/19q codeletion), and type of treatment received will be included. Results will be reported as Hazard Ratio with 95% confidence intervals. Data will be plotted with Kaplan-Meier curves.
Up to 5 years post-diagnosis

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospital Italiano de Buenos Aires

Investigadores

  • Diretor de estudo: Ivan Alfredo Huespe, MD, MPh, Hospital Italiano de Buenos Aires

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de abril de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

31 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

8 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 7339

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

The study team is currently evaluating the feasibility of sharing de-identified individual participant data, taking into account ethical approvals, data privacy regulations, and the resources required for proper anonymization and curation. A final plan will be determined after completion of data collection and primary analyses.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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