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CORALINENCT07773285

Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Start date: Sep 2026 to Nov 2026
    • Eligibility criteria expanded, about 5 words
    • Site details revised
  2. Secondary endpoints: 9 to 10v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Sensitivity of the G8 screening tool for frailty
Timeframe: Baseline
Early Mortality
Timeframe: 6 months
Overall Survival at 12 and 36 months
Timeframe: 12 months and 36 months.

Secondary (10)

Operational Characteristics of the G8 Tool for Frailty
Overall Survival Stratified by G8 Classification
Predictive ability of the G8 score
discrimination and calibration of a risk model
Prevalence of Frailty Indicators
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Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality
Regional disparities in G8 performance
Comparative analysis of G8 versus CGA
Hospitalization rates within 6 months according to G8.
Operational Characteristics of G8 for Survival

Arms and interventions

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

Sites

1 site in 1 country

  • HCOR - Hospital do CoraçãoSão Paulo, São Paulo, Brazil