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 augustus 2026 bijgewerkt door: 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).
Studie Overzicht
Toestand
Nog niet aan het werven
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
250
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Laura Voelcker
- Telefoonnummer: +55 (51) 3384.5334
- E-mail: laura.voelcker@lacog.group
Studie Contact Back-up
- Naam: Ayanie Ribeiro
- Telefoonnummer: +55 (51) 3384.5334
- E-mail: ayanie.ribeiro@lacog.group
Studie Locaties
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São Paulo
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São Paulo, São Paulo, Brazilië, 04004-030
- HCOR - Hospital do Coração
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Contact:
- Luciola Barros
- Telefoonnummer: +5511986740192
- E-mail: luciolaplbarros@gmail.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sensitivity of the G8 screening tool for frailty
Tijdsspanne: Baseline
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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.
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Baseline
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Early Mortality
Tijdsspanne: 6 months
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Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis
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6 months
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Overall Survival at 12 and 36 months
Tijdsspanne: 12 months and 36 months.
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Proportion of participants surviving at 12 months (1 year) and 36 months (3 years) following study inclusion, calculated from enrollment to death or censoring
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12 months and 36 months.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Operational Characteristics of the G8 Tool for Frailty
Tijdsspanne: Baseline
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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).
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Baseline
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Predictive ability of the G8 score
Tijdsspanne: 6 and 36 months
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Area under the receiver operating characteristic (ROC) curve (AUC) evaluating the capacity of the baseline G8 score to predict survival outcomes.
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6 and 36 months
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discrimination and calibration of a risk model
Tijdsspanne: up to 36 months
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Discrimination and calibration metrics of the survival model.
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up to 36 months
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Prevalence of Frailty Indicators
Tijdsspanne: Baseline
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Prevalence of specific frailty indicators, including nutritional status impairment, functional deficit, and cognitive decline.
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Baseline
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Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality
Tijdsspanne: Up to 6 months
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Association between frailty and early mortality with variables such as age, sex, tumor site, comorbidities, functional status
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Up to 6 months
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Regional disparities in G8 performance
Tijdsspanne: Up to 36 months
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To explore regional differences in frailty prevalence and survival outcomes within Brazil
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Up to 36 months
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Comparative analysis of G8 versus CGA
Tijdsspanne: Up to 36 months
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To compare the predictive accuracy of the G8 against the Comprehensive Geriatric Assessment (CGA) and specific geriatric syndromes.
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Up to 36 months
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Hospitalization rates within 6 months according to G8.
Tijdsspanne: Up to 6 months
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To explore the association between G8 scores and complications.
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Up to 6 months
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Overall Survival Stratified by G8 Classification
Tijdsspanne: 6 months and 36 months
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Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score).
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6 months and 36 months
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Operational Characteristics of G8 for Survival
Tijdsspanne: 6 months and 36 months.
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Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the G8 tool to predict mortality.
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6 months and 36 months.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Ludmila Koch, Hospital israelita Albert Einstein
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 november 2027
Studie voltooiing (Geschat)
1 september 2030
Studieregistratiedata
Eerst ingediend
12 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
12 augustus 2026
Eerst geplaatst (Werkelijk)
19 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
24 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- LACOG 0625
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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