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. August 2026 aktualisiert von: 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).
Studienübersicht
Status
Noch keine Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
250
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Laura Voelcker
- Telefonnummer: +55 (51) 3384.5334
- E-Mail: laura.voelcker@lacog.group
Studieren Sie die Kontaktsicherung
- Name: Ayanie Ribeiro
- Telefonnummer: +55 (51) 3384.5334
- E-Mail: ayanie.ribeiro@lacog.group
Studienorte
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São Paulo
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São Paulo, São Paulo, Brasilien, 04004-030
- HCOR - Hospital do Coração
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Kontakt:
- Luciola Barros
- Telefonnummer: +5511986740192
- E-Mail: luciolaplbarros@gmail.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sensitivity of the G8 screening tool for frailty
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Operational Characteristics of the G8 Tool for Frailty
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Ludmila Koch, Hospital israelita Albert Einstein
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
1. November 2027
Studienabschluss (Geschätzt)
1. September 2030
Studienanmeldedaten
Zuerst eingereicht
12. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. August 2026
Zuerst gepostet (Tatsächlich)
19. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LACOG 0625
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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