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NCT07773285
Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil
Conditions: Solid Tumor, Metastatic Solid Tumor, Recurrent Solid Tumor
Sex: All
Ages: 70 Years – N/A
Healthy volunteers: No
Enrollment: 250
Sponsor: Latin American Cooperative Oncology Group
Location: HCOR - Hospital do Coração São Paulo São Paulo
Summary
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
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
Source: ClinicalTrials.gov (NCT07773285). StuddyBuddy aggregates publicly available trial information.