CancerG8-PTNCT07487298
G8 Screening Tool Validation in Older Adults With Cancer in Portugal
An observational study of Cancer and Frailty, run by Hospital de Braga at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- What is being tested?
- G8 Screening Tool and Comprehensive Geriatric Assessment
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Mar 2026to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older adults (≥70 years) with solid malignancies referred for multidisciplinary geriatric oncology evaluation and considered for systemic anticancer treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Hospital de Braga (Unidade Local de Saúde de Braga)
Braga, Braga District, 4710-243
Catarina M Ferreira, MD, +351961139172, ana.c.ferreira@ulsb.min-saude.pt
About this study
Official title: 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.
Read the 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.
- Being tested
- G8 Screening Tool, Comprehensive Geriatric Assessment
- Keywords
- G8 screening tool, geriatric screening, oncogeriatrics, frailty, comprehensive geriatric assessment, CGA, older adults with cancer, geriatric oncology, frailty screening, G8 validation
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G8 Screening ToolOther
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 AssessmentOther
A multidimensional diagnostic process used to evaluate frailty across multiple domains including functional, cognitive, nutritional, and social status.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults With Cancer | Patients aged ≥70 years with a diagnosis of cancer undergoing geriatric assessment, including G8 screening and comprehensive geriatric assessment. Receives: Other: G8 Screening Tool; Other: Comprehensive Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the G8 Screening Tool for Detecting Frailty
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.
Measured: At baseline (single assessment at study inclusion)
Secondary outcomes (3)
Prevalence of Frailty Based on Comprehensive Geriatric Assessment
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.
Measured: At baseline (single assessment at study inclusion)
Agreement Between G8 Screening Tool and Comprehensive Geriatric Assessment
The level of agreement between the G8 screening tool and comprehensive geriatric assessment (CGA) will be evaluated using appropriate statistical measures, including concordance statistics.
Measured: At baseline (single assessment at study inclusion)
Discriminative Ability of the G8 Screening Tool (ROC Curve Analysis)
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.
Measured: At baseline (single assessment at study inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Braga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487298
- Sponsor's protocol ID
- G8-PT-ULSB
- Acronym
- G8-PT
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the G8 Geriatric Screening Tool in Older Adults With Cancer in Portugal (G8-PT Study)
- ClinicalTrials.gov ID
- NCT07487298
- Acronym / sponsor ID
- G8-PT / G8-PT-ULSB
- Keywords
- G8 screening tool, geriatric screening, oncogeriatrics, frailty, comprehensive geriatric assessment, CGA, older adults with cancer, geriatric oncology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital de BragaUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults With Cancer | – | Other: G8 Screening Tool, Other: Comprehensive Geriatric AssessmentPatients aged ≥70 years with a diagnosis of cancer undergoing geriatric assessment, including G8 screening and comprehensive geriatric assessment. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults (≥70 years) with solid malignancies referred for multidisciplinary geriatric oncology evaluation and considered for systemic anticancer treatment.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G8 Screening ToolThe 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 | Older Adults With Cancer |
| Comprehensive Geriatric AssessmentA multidimensional diagnostic process used to evaluate frailty across multiple domains including functional, cognitive, nutritional, and social status. | Other | Older Adults With Cancer |
Primary outcome
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.
3 secondary outcomes
Prevalence of Frailty Based on Comprehensive Geriatric Assessment
Time frame: 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)
Discriminative Ability of the G8 Screening Tool (ROC Curve Analysis)
Time frame: At baseline (single assessment at study inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Frailty, run by Hospital de Braga at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catarina M Ferreira, MD (+351961139172, ana.c.ferreira@ulsb.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the G8 Screening Tool for Detecting Frailty (time frame: At baseline (single assessment at study inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.