Clinical trial · Observational
Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil
Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil - CORALINE (LACOG 0625)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Recurrent Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Prospective Observational Cohort
- description
- 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
Primary outcomes (3)
- measure
- Sensitivity of the G8 screening tool for frailty
- timeFrame
- Baseline
- description
- 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.
- measure
- Early Mortality
- timeFrame
- 6 months
- description
- Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available