About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Sensitivity of the G8 screening tool for frailty
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.
Early Mortality
Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis
Overall Survival at 12 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
Secondary outcomes
Operational Characteristics of the G8 Tool for Frailty
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).
Overall Survival Stratified by G8 Classification
Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score).
Predictive ability of the G8 score
Area under the receiver operating characteristic (ROC) curve (AUC) evaluating the capacity of the baseline G8 score to predict survival outcomes.
discrimination and calibration of a risk model
Discrimination and calibration metrics of the survival model.
Sponsors and contacts
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