Low-grade GliomaNCT07631338
Low-grade Gliomas in Argentina: Incidence, Survival, and Therapeutic Strategies
An observational study of Low-grade Glioma, run by Hospital Italiano de Buenos Aires at 6 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low-grade Glioma
- How many people
- 40 participants
- Where
- 6 sitesArgentina
- Study dates
- 1 Apr 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Adult patients (≥18 years) with histopathologically confirmed diagnosis of low-grade glioma (WHO grades I and II).
Who cannot join
- Patients not affiliated to the health plan of the Hospital Italiano de Buenos Aires.
- Study population cohort 2
- Incomplete or doubtful diagnosis based on histopathologic and molecular criteria.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Argentina6 sites, 6 recruiting
- Recruiting
Hospital Alemán
Buenos Aires, Buenos Aires F.D., C1118AAT
Daniel Ignacio Ivulich, MD, +5491161859413, di.ivulich@gmail.com
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., C1199ABB
Ivan Alfredo Huespe, MD, MPh, +5493425382554, ivan.huespe@hospitalitaliano.org.ar
- Recruiting
Hospital de Alta Complejidad El Cruce - Dr. Néstor Kirchner
Buenos Aires, Florencio Varela, B1888
Maximiliano Núñez, MD, +5492216061422, maxineuro@gmail.com
- Recruiting
Hospital Universitario Austral
Buenos Aires, Pilar, B1629AHJ
Alicia Gira, MD, +5491126336442, aliciaroxanagira@gmail.com
- Recruiting
Hospital Italiano sede San Justo Agustín Rocca
Buenos Aires, San Justo, C1198AAW
Veronica Ester Monzon, MD, +5491165846854, veronica.monzon@hospitalitaliano.org.ar
- Recruiting
Hospital Privado Universitario de Córdoba
Córdoba, Córdoba Province, X5016KEH
Emiliano Tornu, MD, +5491164073575, emilianocornu@gmail.com
About this study
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Low-grade Glioma
- Keywords
- Low-grade glioma, Glioma, Brain tumor, Neuro-oncology, Incidence, Survival
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: January 2011 - December 2023
Secondary 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.
Measured: Up to 5 years post-diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Apr 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan A. Huespe, Hospital Italiano de Buenos Aires
- Investigators
- Ivan Alfredo Huespe, MD, MPh, Study director, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631338
- Sponsor's protocol ID
- 7339
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-grade Gliomas in Argentina: Incidence, Survival, and Therapeutic Strategies
- ClinicalTrials.gov ID
- NCT07631338
- Acronym / sponsor ID
- 7339
- Conditions
- Low-grade Glioma
- Keywords
- Low-grade glioma, Glioma, Brain tumor, Neuro-oncology, Incidence, Survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
Key exclusion criteria (3 listed)
- Study population cohort 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the incidence density of LGG
Time frame: 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.
Generate an Argentine population projection model
Time frame: 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.
Describe overall survival (OS) and disease-free survival (DFS)
Time frame: 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.
Describe the treatment strategies implemented in patients with LGG in public and private institutions
Time frame: 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.
1 secondary outcome
Evaluate factors associated with shorter time to death or death and relapse
Time frame: Up to 5 years post-diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Low-grade Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 2
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
BRAF V600 Mutation, Low-grade Glioma
Active, not recruitingPhase 2
Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
Glioma, Glioblastoma
Active, not recruitingPhase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivan Alfredo Huespe, MD, MPh study director
Hospital Italiano de Buenos Aires
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low-grade Glioma, run by Hospital Italiano de Buenos Aires at 6 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Alfredo Huespe, MD, MPh (+5493425382554, ivan.huespe@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the incidence density of LGG (time frame: January 2011 - December 2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.