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

NCT07773285 | Not Yet Recruiting

• 1 other identifier: LACOG 0625
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Solid Tumor; Metastatic Solid Tumor; Recurrent Solid Tumor

Keywords

Metastatic or recurrent cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Operational Characteristics of the G8 Tool for Frailty

  Baseline

• Overall Survival Stratified by G8 Classification

  6 months and 36 months

• Predictive ability of the G8 score

  6 and 36 months

• discrimination and calibration of a risk model

  up to 36 months

• Prevalence of Frailty Indicators

  Baseline

Study Arms (1)

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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
• Be able to understand and provide informed consent (ICF).

You may not qualify if:

• \. Nonmelanoma skin cancer

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead

Study Sites (1)

HCOR - Hospital do Coração

São Paulo, São Paulo, 04004-030, Brazil

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Recurrence

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Ludmila Koch

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayanie Ribeiro

CONTACT

+55 (51) 3384.5334; ayanie.ribeiro@lacog.group

Laura Voelcker

CONTACT

+55 (51) 3384.5334; laura.voelcker@lacog.group

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)