Low-grade Gliomas in Argentina: Incidence, Survival, and Therapeutic Strategies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 6
Study Overview
Brief Summary
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:
- Cohort 1: The "captive" population covered under the Hospital Italiano de Buenos Aires Health Plan (January 2011-December 2023) to estimate LGG incidence density.
- 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.
Detailed Description
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Investigators
Ivan A. Huespe
Principal Investigator
Hospital Italiano de Buenos Aires