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NCT Number: NCT07773285

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

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).

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Key information

Conditions

Solid Tumor Disease Attributes Metastatic Solid Tumor Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent Solid Tumor

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • Nonmelanoma skin cancer

Treatment and study plan

Primary outcomes

  1. Sensitivity of the G8 screening tool for frailty

    Time frame: Baseline

    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.

  2. Early Mortality

    Time frame: Death within 6 months of enrollment

    Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis

  3. Overall Survival at 12 and 36 months

    Time frame: 12 months and 36 months post-enrollment.

    Proportion of participants surviving at 12 months (1 year) and 36 months (3 years) following study inclusion, calculated from enrollment to death or censoring

Secondary outcomes

  1. Operational Characteristics of the G8 Tool for Frailty

    Time frame: Baseline

    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).

  2. Operational Characteristics of G8 for 6-Month and 36-Month Survival

    Time frame: 6 months and 36 months

    Sensitivity and Specificity of the G8 score for predicting landmark mortality at 6 and 36 months.

  3. Predictive ability of the G8 score

    Time frame: 6 and 36 months

    Area under the receiver operating characteristic (ROC) curve (AUC) evaluating the capacity of the baseline G8 score to predict survival outcomes.

  4. discrimination and calibration of a risk model

    Time frame: up to 36 months

    Discrimination and calibration metrics of the survival model.

  5. Prevalence of Frailty Indicators

    Time frame: Baseline

    Prevalence of specific frailty indicators, including nutritional status impairment, functional deficit, and cognitive decline.

  6. Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality

    Time frame: Up to 6 months

    Association between frailty and early mortality with variables such as age, sex, tumor site, comorbidities, functional status

  7. Regional disparities in G8 performance

    Time frame: Up to 36 months

    To explore regional differences in frailty prevalence and survival outcomes within Brazil

  8. Comparative analysis of G8 versus CGA

    Time frame: Up to 36 months

    To compare the predictive accuracy of the G8 against the Comprehensive Geriatric Assessment (CGA) and specific geriatric syndromes.

  9. Hospitalization rates within 6 months according to G8.

    Time frame: Up to 6 months

    To explore the association between G8 scores and complications.

Study contacts

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

Ayanie Ribeiro

CONTACT

[email protected]

+55 (51) 3384.5334

Laura Voelcker

CONTACT

[email protected]

+55 (51) 3384.5334

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Registry information

Official study title

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)

Acronym: CORALINE

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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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