Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorLatin American Cooperative Oncology Group

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Aged 70 or above

Diagnosis of cancer (solid tumors)

Metastatic or recurrent cancer (treatment-naïve) regardless of the interval from prior localized disease

Intention to start first systemic line of therapy

Disqualifiers

None

Trial population

The study population will consist of 250 individuals aged ≥70 years with a new diagnosis of solid tumors, enrolled from different regions of Brazil. Eligible individuals will be identified and invited to participate after ethics committee approval and informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 1 trial group
Group A: Prospective Observational Cohort

Trial outcomes

Primary outcomes

1

Sensitivity of the G8 screening tool for frailty

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.

Time frame
Baseline
2

Early Mortality

Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis

Time frame
6 months
3

Overall Survival at 12 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

Time frame
12 months and 36 months.

Secondary outcomes

1

Operational Characteristics of the G8 Tool for Frailty

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).

Time frame
Baseline
2

Overall Survival Stratified by G8 Classification

Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score).

Time frame
6 months and 36 months
3

Predictive ability of the G8 score

Area under the receiver operating characteristic (ROC) curve (AUC) evaluating the capacity of the baseline G8 score to predict survival outcomes.

Time frame
6 and 36 months
4

discrimination and calibration of a risk model

Discrimination and calibration metrics of the survival model.

Time frame
up to 36 months

Other outcomes

Sponsors and contacts

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