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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07773285). StuddyBuddy aggregates publicly available trial information.