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NCT Number: NCT07487298

G8 Screening Tool Validation in Older Adults With Cancer in Portugal

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Braga (Unidade Local de Saúde de Braga)

Braga, Braga District, 4710-243, Portugal

Location contact

Catarina M Ferreira, MD

CONTACT

[email protected]

+351961139172

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

G8 Screening Tool

Other

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.

Comprehensive Geriatric Assessment

Other

A multidimensional diagnostic process used to evaluate frailty across multiple domains including functional, cognitive, nutritional, and social status.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Catarina M Ferreira, MD

CONTACT

[email protected]

+351961139172

Sponsors and collaborators

Lead sponsor

Hospital de Braga

Other

Registry information

Official study title

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

Acronym: G8-PT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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