Low-grade Gliomas in Argentina: Incidence, Survival, and Therapeutic Strategies
ConditionLow-grade Glioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Italiano de Buenos Aires
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* 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.
Disqualifiers
Patients not affiliated to the health plan of the Hospital Italiano de Buenos Aires.
Inclusion Criteria
Adult patients (≥18 years) with histopathologically confirmed diagnosis of low-grade glioma (WHO grades I and II).
Exclusion Criteria
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Cohort 1: Incidence cohort
Group B: Cohort 2: Survival cohort
Trial outcomes
Primary outcomes
1
Describe the incidence density of LGG
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.
Time frame
January 2011 - December 20232
Generate an Argentine population projection model
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.
Time frame
January 2011 - December 20233
Describe overall survival (OS) and disease-free survival (DFS)
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.
Time frame
Up to 5 years post-diagnosis4
Describe the treatment strategies implemented in patients with LGG in public and private institutions
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.
Time frame
January 2011 - December 2023Secondary outcomes
1
Evaluate factors associated with shorter time to death or death and relapse
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.
Time frame
Up to 5 years post-diagnosisSponsors and contacts
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Source ClinicalTrials.gov