Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil
- Sponsor
- Latin American Cooperative Oncology Group
- Study ID
- NCT07773285
- Status
- Not Yet Recruiting
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Conditions
- Metastatic Solid Tumor
- Recurrent Solid Tumor
- Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 70 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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).
Key Dates
- First listed
- Aug 19, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Nov 30, 2027
- Completion
- Sep 30, 2030
Study Design
- Enrollment
- 250 participants (estimated)
Arms
- Arm: Prospective Observational Cohortindividuals aged 70 years or older newly diagnosed with metastatic or recurrent solid tumors (treatment-naïve ) regardless of the interval from prior localized disease tradução
Primary Outcome Measure
Sensitivity of the G8 screening tool for frailty [ Time Frame: Baseline ]
Central Contacts
- Ayanie Ribeiro+55 (51) 3384.5334
- Laura Voelcker+55 (51) 3384.5334
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