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 augusti 2026 uppdaterad av: 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).
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
250
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Laura Voelcker
- Telefonnummer: +55 (51) 3384.5334
- E-post: laura.voelcker@lacog.group
Studera Kontakt Backup
- Namn: Ayanie Ribeiro
- Telefonnummer: +55 (51) 3384.5334
- E-post: ayanie.ribeiro@lacog.group
Studieorter
-
-
São Paulo
-
São Paulo, São Paulo, Brasilien, 04004-030
- HCOR - Hospital do Coração
-
Kontakt:
- Luciola Barros
- Telefonnummer: +5511986740192
- E-post: luciolaplbarros@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sensitivity of the G8 screening tool for frailty
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Operational Characteristics of the G8 Tool for Frailty
Tidsram: 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
Tidsram: 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
Tidsram: up to 36 months
|
Discrimination and calibration metrics of the survival model.
|
up to 36 months
|
|
Prevalence of Frailty Indicators
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: Up to 6 months
|
To explore the association between G8 scores and complications.
|
Up to 6 months
|
|
Overall Survival Stratified by G8 Classification
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Ludmila Koch, Hospital israelita Albert Einstein
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 november 2027
Avslutad studie (Beräknad)
1 september 2030
Studieregistreringsdatum
Först inskickad
12 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
12 augusti 2026
Första postat (Faktisk)
19 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LACOG 0625
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .