Low-grade Gliomas in Argentina: Incidence, Survival, and Therapeutic Strategies
2026년 6월 1일 업데이트: 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:
- 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.
연구 개요
상태
상태
모병
정황
정황
상세 설명
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.
연구 유형
연구 유형
관찰
등록 (추정된)
등록
40
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Ivan Alfredo Huespe, MD, MPh
- 전화번호: +5493425382554
- 이메일: ivan.huespe@hospitalitaliano.org.ar
연구 연락처 백업
- 이름: Veronica Ester Monzon, MD
- 전화번호: +5491165846854
- 이메일: veronica.monzon@hospitalitaliano.org.ar
연구 장소
-
-
Buenos Aires F.D.
-
Buenos Aires, Buenos Aires F.D., 아르헨티나, C1118AAT
- 모병
- Hospital Aleman
-
연락하다:
- Daniel Ignacio Ivulich, MD
- 전화번호: +5491161859413
- 이메일: di.ivulich@gmail.com
-
Buenos Aires, Buenos Aires F.D., 아르헨티나, C1199ABB
- 모병
- Hospital Italiano de Buenos Aires
-
연락하다:
- Ivan Alfredo Huespe, MD, MPh
- 전화번호: +5493425382554
- 이메일: ivan.huespe@hospitalitaliano.org.ar
-
-
Córdoba Province
-
Córdoba, Córdoba Province, 아르헨티나, X5016KEH
- 모병
- Hospital Privado Universitario de Córdoba
-
연락하다:
- Emiliano Tornu, MD
- 전화번호: +5491164073575
- 이메일: emilianocornu@gmail.com
-
-
Florencio Varela
-
Buenos Aires, Florencio Varela, 아르헨티나, B1888
- 모병
- Hospital de Alta Complejidad El Cruce - Dr. Néstor Kirchner
-
연락하다:
- Maximiliano Núñez, MD
- 전화번호: +5492216061422
- 이메일: maxineuro@gmail.com
-
-
Pilar
-
Buenos Aires, Pilar, 아르헨티나, B1629AHJ
- 모병
- Hospital Universitario Austral
-
연락하다:
- Alicia Gira, MD
- 전화번호: +5491126336442
- 이메일: aliciaroxanagira@gmail.com
-
-
San Justo
-
Buenos Aires, San Justo, 아르헨티나, C1198AAW
- 모병
- Hospital Italiano sede San Justo Agustín Rocca
-
연락하다:
- Veronica Ester Monzon, MD
- 전화번호: +5491165846854
- 이메일: veronica.monzon@hospitalitaliano.org.ar
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
2
코호트 및 개입
그룹/코호트그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Describe the incidence density of LGG
기간: 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
기간: 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)
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluate factors associated with shorter time to death or death and relapse
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Ivan Alfredo Huespe, MD, MPh, Hospital Italiano de Buenos Aires
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 4월 1일
기본 완료 (추정된)
기본 완료
2027년 2월 1일
연구 완료 (추정된)
연구 완료
2027년 5월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 1일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 7339
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .