G8 Screening Tool Validation in Older Adults With Cancer in Portugal (G8-PT)

March 17, 2026 updated by: Hospital de Braga

Prospective Validation of the G8 Geriatric Screening Tool in Older Adults With Cancer in Portugal (G8-PT Study)

The G8 screening tool is widely recommended for the identification of frailty in older adults with cancer. However, prospective validation data in the Portuguese population are currently lacking.

This prospective observational study aims to evaluate the diagnostic performance of the G8 screening tool compared with a Comprehensive Geriatric Assessment (CGA) in older adults with cancer. Patients aged ≥70 years with solid tumors will be assessed using both the G8 screening tool and a multidimensional CGA. Frailty will be defined as impairment in at least one CGA domain. The performance of the G8 will be evaluated in terms of sensitivity, specificity, and area under the receiver operating characteristic curve.

This study aims to provide the first prospective validation of the G8 screening tool in Portuguese older adults with cancer and to support its implementation in clinical practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Older adults represent a growing proportion of the oncology population and are characterized by significant heterogeneity in functional status, comorbidities, and physiological reserve. These factors may influence treatment tolerance, toxicity, and clinical outcomes.

International guidelines from European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), and International Society of Geriatric Oncology (SIOG) recommend the use of geriatric assessment to guide treatment decisions in older adults with cancer. The Comprehensive Geriatric Assessment (CGA) is considered the reference standard for evaluating multiple health domains, including functional status, cognition, nutrition, psychological state, social support, and comorbidities. However, its routine implementation is limited by time and resource constraints.

The G8 screening tool is a rapid geriatric screening instrument developed specifically for older patients with cancer. It consists of eight items derived mainly from the Mini Nutritional Assessment, along with additional clinical parameters such as age, mobility, polypharmacy, and self-perceived health status. A score ≤14 is generally considered indicative of frailty and the need for further assessment.

Although the G8 has been validated in several international settings, prospective validation data in the Portuguese population are lacking.

This prospective observational study aims to evaluate the diagnostic accuracy of the G8 screening tool compared with a multidimensional CGA in older adults with cancer in Portugal. Frailty will be defined as impairment in at least one CGA domain.

To our knowledge, this study represents the first prospective validation of the G8 screening tool in Portuguese older adults with cancer. The results of this study may support the implementation of geriatric screening strategies and improve clinical decision-making in oncogeriatric care in Portugal.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
    • Braga District
      • Braga, Braga District, Portugal, 4710-243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Older adults (≥70 years) with solid malignancies referred for multidisciplinary geriatric oncology evaluation and considered for systemic anticancer treatment.

Description

Inclusion Criteria:

  • Age ≥70 years;
  • Histologically confirmed solid malignancy, regardless of tumor site or stage;
  • Referral to a multidisciplinary geriatric oncology consultation;
  • Consideration for or planned systemic anticancer treatment;
  • Ability to understand and respond to assessment tools (G8 and comprehensive geriatric assessment), with or without caregiver assistance;
  • Provision of written informed consent by the patient or legal representative.

Exclusion Criteria:

  • Age <70 years;
  • Diagnosis of hematological malignancy (e.g., leukemia, lymphoma, multiple myeloma);
  • Severe cognitive impairment precluding completion of assessment tools without available caregiver support;
  • Clinical instability or acute condition preventing data collection (e.g., hospitalization for acute complication);
  • Refusal to participate or inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Older Adults With Cancer
Patients aged ≥70 years with a diagnosis of cancer undergoing geriatric assessment, including G8 screening and comprehensive geriatric assessment.
Other: G8 Screening Tool
The G8 is a screening tool used to identify frailty in older patients with cancer and to select those who may benefit from a comprehensive geriatric assessment.
Other: Comprehensive Geriatric Assessment
A multidimensional diagnostic process used to evaluate frailty across multiple domains including functional, cognitive, nutritional, and social status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of the G8 Screening Tool for Detecting Frailty
Time Frame: At baseline (single assessment at study inclusion)
The diagnostic performance of the G8 screening tool will be evaluated against comprehensive geriatric assessment (CGA) as the reference standard. Measures will include sensitivity, specificity, positive predictive value, and negative predictive value for identifying frailty.
At baseline (single assessment at study inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Frailty Based on Comprehensive Geriatric Assessment
Time Frame: At baseline (single assessment at study inclusion)
The prevalence of frailty will be determined based on comprehensive geriatric assessment (CGA), defined as the presence of at least one impaired domain according to predefined criteria.
At baseline (single assessment at study inclusion)
Agreement Between G8 Screening Tool and Comprehensive Geriatric Assessment
Time Frame: At baseline (single assessment at study inclusion)
The level of agreement between the G8 screening tool and comprehensive geriatric assessment (CGA) will be evaluated using appropriate statistical measures, including concordance statistics.
At baseline (single assessment at study inclusion)
Discriminative Ability of the G8 Screening Tool (ROC Curve Analysis)
Time Frame: At baseline (single assessment at study inclusion)
The discriminative performance of the G8 screening tool for identifying frailty will be assessed using receiver operating characteristic (ROC) curve analysis, including calculation of the area under the curve (AUC) and identification of optimal cut-off values.
At baseline (single assessment at study inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Braga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G8-PT-ULSB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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