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

NCT07631338 | Recruiting

• 1 other identifier: 7339
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 6

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:

1. 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. 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.

Conditions

Low-grade Glioma

Keywords

Low-grade glioma; Glioma; Brain tumor; Neuro-oncology; Incidence; Survival

Outcome Measures

Primary Outcomes (4)

• 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.

  January 2011 - December 2023

• 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.

  January 2011 - December 2023

• 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.

  Up to 5 years post-diagnosis

• 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.

  January 2011 - December 2023

Secondary Outcomes (1)

• Evaluate factors associated with shorter time to death or death and relapse

  Up to 5 years post-diagnosis

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients not affiliated to the health plan of the Hospital Italiano de Buenos Aires.
• Study population cohort 2
• Adult patients (≥18 years) with histopathologically confirmed diagnosis of low-grade glioma (WHO grades I and II).
• Incomplete or doubtful diagnosis based on histopathologic and molecular criteria.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (6)

Hospital Alemán

Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

RECRUITING

Hospital Privado Universitario de Córdoba

Córdoba, Córdoba Province, X5016KEH, Argentina

RECRUITING

Hospital de Alta Complejidad El Cruce - Dr. Néstor Kirchner

Buenos Aires, Florencio Varela, B1888, Argentina

RECRUITING

Hospital Universitario Austral

Buenos Aires, Pilar, B1629AHJ, Argentina

RECRUITING

Hospital Italiano sede San Justo Agustín Rocca

Buenos Aires, San Justo, C1198AAW, Argentina

RECRUITING

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ivan Alfredo Huespe, MD, MPh

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

Central Study Contacts

Ivan Alfredo Huespe, MD, MPh

CONTACT

+5493425382554; ivan.huespe@hospitalitaliano.org.ar

Veronica Ester Monzon, MD

CONTACT

+5491165846854; veronica.monzon@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

AR (6)