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)

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)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor; Metastatic Solid Tumor; Recurrent Solid Tumor

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Laura Voelcker; Phone Number: +55 (51) 3384.5334; Email: laura.voelcker@lacog.group
• Study Contact Backup: Name: Ayanie Ribeiro; Phone Number: +55 (51) 3384.5334; Email: ayanie.ribeiro@lacog.group

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04004-030
      • HCOR - Hospital do Coração
      • Contact: Luciola Barros; Phone Number: +5511986740192; Email: luciolaplbarros@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Prospective Observational Cohort; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
Early Mortality	Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis	6 months
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	12 months and 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline
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.	6 and 36 months
discrimination and calibration of a risk model	Discrimination and calibration metrics of the survival model.	up to 36 months
Prevalence of Frailty Indicators	Prevalence of specific frailty indicators, including nutritional status impairment, functional deficit, and cognitive decline.	Baseline
Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality	Association between frailty and early mortality with variables such as age, sex, tumor site, comorbidities, functional status	Up to 6 months
Regional disparities in G8 performance	To explore regional differences in frailty prevalence and survival outcomes within Brazil	Up to 36 months
Comparative analysis of G8 versus CGA	To compare the predictive accuracy of the G8 against the Comprehensive Geriatric Assessment (CGA) and specific geriatric syndromes.	Up to 36 months
Hospitalization rates within 6 months according to G8.	To explore the association between G8 scores and complications.	Up to 6 months
Overall Survival Stratified by G8 Classification	Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score).	6 months and 36 months
Operational Characteristics of G8 for Survival	Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the G8 tool to predict mortality.	6 months and 36 months.

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Investigators: Principal Investigator: Ludmila Koch, Hospital israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic or recurrent cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Recurrence; Neoplasm Metastasis
• Other Study ID Numbers: LACOG 0625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No