Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil (CORALINE)
24 août 2026 mis à jour par: Latin American Cooperative Oncology Group
Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil - CORALINE (LACOG 0625)
This is a prospective observational cohort study including 250 individuals aged 70 years or older newly diagnosed with solid tumors. In this non-interventional study, all patient contacts will be conducted via telephone or video call.
After obtaining informed consent which will be conducted electronically, an initial telemedicine assessment will be performed. During this evaluation, sociodemographic and clinical data will be collected, and a Comprehensive Geriatric Assessment (CGA) will be conducted. The assessment will be performed by a trained professional using internationally recognized, validated instruments that are preferably culturally adapted to the Brazilian population. The G8 score will be calculated based on information collected at baseline. Additionally, medication use, the Charlson Comorbidity Index, Mini Nutritional Assessment, and self-rated health status will be recorded. The total G8 score ranges from 0 to 17, with higher scores indicating better health status (abnormal G8 score ≤14).
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
There will be no access to or review of medical records in this study; all information will be obtained directly from participants through telemedicine assessments and follow-up contacts.
Participants will continue to receive treatment and clinical evaluations as determined by their treating physicians, according to standard clinical practice.
No intervention is proposed in this study.
Participants will be contacted for follow-up at 3, 6, 12, 18, 24, and 36 months.
During follow-up, information regarding treatment continuation, treatment discontinuation due to toxicity, and survival status will be collected.
The primary endpoints are overall survival and early mortality, defined as death occurring within six months after study inclusion, as well as overall survival at 1 year and 3 years.
Following approval by the Research Ethics Committee, the study will be conducted in a decentralized manner, with recruitment occurring through spontaneous demand or referral by treating physicians from different institutions, preferably among investigators affiliated with LACOG who are aware of the study protocol.
Type d'étude
Observationnel
Inscription (Estimé)
250
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Laura Voelcker
- Numéro de téléphone: +55 (51) 3384.5334
- E-mail: laura.voelcker@lacog.group
Sauvegarde des contacts de l'étude
- Nom: Ayanie Ribeiro
- Numéro de téléphone: +55 (51) 3384.5334
- E-mail: ayanie.ribeiro@lacog.group
Lieux d'étude
-
-
São Paulo
-
São Paulo, São Paulo, Brésil, 04004-030
- HCOR - Hospital do Coração
-
Contact:
- Luciola Barros
- Numéro de téléphone: +5511986740192
- E-mail: luciolaplbarros@gmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
The study population will consist of 250 individuals aged ≥70 years with a new diagnosis of solid tumors, enrolled from different regions of Brazil.
Eligible individuals will be identified and invited to participate after ethics committee approval and informed consent.
La description
Inclusion Criteria:
- Aged 70 or above
- Diagnosis of cancer (solid tumors)
- Metastatic or recurrent cancer (treatment-naïve) regardless of the interval from prior localized disease
- Intention to start first systemic line of therapy
- Be able to understand and provide informed consent (ICF).
Exclusion Criteria:
1. Nonmelanoma skin cancer
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Prospective Observational Cohort
individuals aged 70 years or older newly diagnosed with metastatic or recurrent solid tumors (treatment-naïve ) regardless of the interval from prior localized disease tradução
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sensitivity of the G8 screening tool for frailty
Délai: Baseline
|
Evaluation of the sensitivity of the Geriatric 8 (G8) tool as a screening instrument for frailty (defined by Comprehensive Geriatric Assessment/CGA) in older adults (+70 years) newly diagnosed with solid tumors.
|
Baseline
|
|
Early Mortality
Délai: 6 months
|
Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis
|
6 months
|
|
Overall Survival at 12 and 36 months
Délai: 12 months and 36 months.
|
Proportion of participants surviving at 12 months (1 year) and 36 months (3 years) following study inclusion, calculated from enrollment to death or censoring
|
12 months and 36 months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Operational Characteristics of the G8 Tool for Frailty
Délai: Baseline
|
Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the G8 score as a screening tool for frailty compared to Comprehensive Geriatric Assessment (CGA).
|
Baseline
|
|
Predictive ability of the G8 score
Délai: 6 and 36 months
|
Area under the receiver operating characteristic (ROC) curve (AUC) evaluating the capacity of the baseline G8 score to predict survival outcomes.
|
6 and 36 months
|
|
discrimination and calibration of a risk model
Délai: up to 36 months
|
Discrimination and calibration metrics of the survival model.
|
up to 36 months
|
|
Prevalence of Frailty Indicators
Délai: Baseline
|
Prevalence of specific frailty indicators, including nutritional status impairment, functional deficit, and cognitive decline.
|
Baseline
|
|
Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality
Délai: Up to 6 months
|
Association between frailty and early mortality with variables such as age, sex, tumor site, comorbidities, functional status
|
Up to 6 months
|
|
Regional disparities in G8 performance
Délai: Up to 36 months
|
To explore regional differences in frailty prevalence and survival outcomes within Brazil
|
Up to 36 months
|
|
Comparative analysis of G8 versus CGA
Délai: Up to 36 months
|
To compare the predictive accuracy of the G8 against the Comprehensive Geriatric Assessment (CGA) and specific geriatric syndromes.
|
Up to 36 months
|
|
Hospitalization rates within 6 months according to G8.
Délai: Up to 6 months
|
To explore the association between G8 scores and complications.
|
Up to 6 months
|
|
Overall Survival Stratified by G8 Classification
Délai: 6 months and 36 months
|
Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score).
|
6 months and 36 months
|
|
Operational Characteristics of G8 for Survival
Délai: 6 months and 36 months.
|
Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the G8 tool to predict mortality.
|
6 months and 36 months.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Ludmila Koch, Hospital israelita Albert Einstein
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 novembre 2027
Achèvement de l'étude (Estimé)
1 septembre 2030
Dates d'inscription aux études
Première soumission
12 août 2026
Première soumission répondant aux critères de contrôle qualité
12 août 2026
Première publication (Réel)
19 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LACOG 0625
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .