Metastatic Solid Tumor, Recurrent Solid Tumor, Solid Tumor
Conditions
Keywords
Metastatic or recurrent cancer
Brief 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).
Detailed description
There will be no access to or review of medical records in this study; all information will be obtained directly from participants through telemedicine assessments and follow-up contacts. Participants will continue to receive treatment and clinical evaluations as determined by their treating physicians, according to standard clinical practice. No intervention is proposed in this study. Participants will be contacted for follow-up at 3, 6, 12, 18, 24, and 36 months. During follow-up, information regarding treatment continuation, treatment discontinuation due to toxicity, and survival status will be collected. The primary endpoints are overall survival and early mortality, defined as death occurring within six months after study inclusion, as well as overall survival at 1 year and 3 years. Following approval by the Research Ethics Committee, the study will be conducted in a decentralized manner, with recruitment occurring through spontaneous demand or referral by treating physicians from different institutions, preferably among investigators affiliated with LACOG who are aware of the study protocol.
Interventions
None listed
Sponsors
Latin American Cooperative Oncology Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the G8 screening tool for frailty | Baseline | 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 | 6 months | Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis |
| Overall Survival at 12 and 36 months | 12 months 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
| Measure | Time frame | Description |
|---|---|---|
| Operational Characteristics of the G8 Tool for Frailty | Baseline | 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 | 6 months and 36 months | Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score). |
| Predictive ability of the G8 score | 6 and 36 months | 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 | up to 36 months | Discrimination and calibration metrics of the survival model. |
| Prevalence of Frailty Indicators | Baseline | Prevalence of specific frailty indicators, including nutritional status impairment, functional deficit, and cognitive decline. |
| Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality | Up to 6 months | Association between frailty and early mortality with variables such as age, sex, tumor site, comorbidities, functional status |
| Regional disparities in G8 performance | Up to 36 months | To explore regional differences in frailty prevalence and survival outcomes within Brazil |
| Comparative analysis of G8 versus CGA | Up to 36 months | To compare the predictive accuracy of the G8 against the Comprehensive Geriatric Assessment (CGA) and specific geriatric syndromes. |
| Hospitalization rates within 6 months according to G8. | Up to 6 months | To explore the association between G8 scores and complications. |
| Operational Characteristics of G8 for Survival | 6 months and 36 months. | Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the G8 tool to predict mortality. |
Countries
Brazil
Contacts
CONTACTAyanie Ribeiro
CONTACTLaura Voelcker
PRINCIPAL_INVESTIGATORLudmila Koch
Hospital Israelita Albert Einstein
Outcome results
None listed