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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 opdateret af: 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Brasilien
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 04004-030

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  1. Aged 70 or above
  2. Diagnosis of cancer (solid tumors)
  3. Metastatic or recurrent cancer (treatment-naïve) regardless of the interval from prior localized disease
  4. Intention to start first systemic line of therapy
  5. Be able to understand and provide informed consent (ICF).

Exclusion Criteria:

1. Nonmelanoma skin cancer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity of the G8 screening tool for frailty
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Operational Characteristics of the G8 Tool for Frailty
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to 36 months
Discrimination and calibration metrics of the survival model.
up to 36 months
Prevalence of Frailty Indicators
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: Up to 6 months
To explore the association between G8 scores and complications.
Up to 6 months
Overall Survival Stratified by G8 Classification
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Latin American Cooperative Oncology Group

Efterforskere

  • Ledende efterforsker: Ludmila Koch, Hospital israelita Albert Einstein

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. september 2030

Datoer for studieregistrering

Først indsendt

12. august 2026

Først indsendt, der opfyldte QC-kriterier

12. august 2026

Først opslået (Faktiske)

19. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LACOG 0625

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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