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

1 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

40

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Describe the incidence density of LGG
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluate factors associated with shorter time to death or death and relapse
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital Italiano de Buenos Aires

Investigatori

  • Direttore dello studio: Ivan Alfredo Huespe, MD, MPh, Hospital Italiano de Buenos Aires

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

31 maggio 2027

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 7339

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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