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NCT Number: NCT07805642

Oncogeriatric Screening and Evaluation Program

This study aims to develop, train, and validate a machine learning-based prediction model (PROTEGER) to provide treatment decision recommendations for older adults diagnosed with solid tumor cancers. The study has a two-phase observational design: a retrospective cohort using anonymized data from an oncogeriatric telecommittee to train the predictive model, followed by a prospective multicenter cohort across Chile, Peru, and Brazil. Information from Comprehensive Geriatric Assessments (CGA), treatment decisions, and 3- and 6-month clinical outcomes will be collected to evaluate and validate the decision-support platform's performance in assisting oncology teams.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BR192 HCOR - Hospital do Coração, São Paulo, Brazil

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About this study

Cancer incidence increases significantly with age, and up to 70% of cancer mortality occurs in patients aged 65 years or older. Despite this, older patients are frequently undertreated due to the high risk of secondary toxicity, which is associated with quality of life deterioration, increased hospitalizations, and higher mortality. Comprehensive Geriatric Assessment (CGA) has proven to be an effective tool to identify vulnerability, reduce chemotherapy-related toxicity, and tailor interventions. However, the lack of geriatricians, especially in Latin American public health systems, creates significant barriers to accessing CGA-guided oncological care.

To overcome these barriers, the PROTEGER program proposes an innovative digital health solution by developing and validating a machine learning-based clinical decision support system (CDSS) for oncogeriatric care. The study is an observational, multicenter, bidirectional cohort study conducted in two phases:

Phase 1: Retrospective Training Phase This phase uses anonymized clinical data (2021-2023) from the Oncogeriatric Tele-Committee of the Chilean Ministry of Health's Digital Hospital. Data from older patients with solid tumors who underwent a CGA will be used to train and test predictive models using machine learning techniques (e.g., Gradient Boosting Trees and Random Forest) following the CRISP-DM methodology. The predictive model aims to learn the Committee's treatment recommendation patterns based on patient functionality, comorbidities, and geriatric syndromes.

Phase 2: Prospective Validation Phase A prospective, multicenter cohort will be enrolled across healthcare centers in Chile, Peru, and Brazil. Eligible patients (aged 65+ with a solid tumor diagnosis) who undergo routine CGA and oncological care will be followed for 6 months. Data regarding baseline characteristics, treatment decisions (made by local oncology teams blinded to the AI model's recommendation), dose reductions, treatment discontinuation, disease progression, quality of life (EORTC QLQ-C30 and ELD14), and survival will be collected.

Study Objectives:

The primary objective is to develop, train, and clinically validate the PROTEGER machine learning predictive model to provide an accurate treatment recommendation (e.g., standard treatment, dose-adjusted treatment, or supportive care only) capable of assisting clinical decision-making by oncology teams. A secondary objective involves the design and development of an intuitive graphical user interface capable of being used by healthcare providers and patients for data management and result interpretation.

All predictive models will be evaluated using standard metrics, such as the Area Under the ROC Curve (AUC) and the C-statistic, to determine their discriminatory capacity in a real-world clinical setting.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 65 years or older.
  • Diagnosis of solid tumor cancer.
  • Must have been evaluated and followed up by a local oncology team.
  • Signed Informed Consent Form (ICF) applied in accordance with the local ethics committee.
  • Must have undergone a Comprehensive Geriatric Assessment (CGA).

Exclusion criteria

  • Patients who are unable or unwilling to consent to providing information will be excluded.

Treatment and study plan

Primary outcomes

  1. Predictive Accuracy of the PROTEGER Machine Learning Model

    Time frame: Up to 6 months post-enrollment.

    Discrimination performance of the machine learning predictive model in recommending oncogeriatric treatment decisions (standard treatment, dose-adjusted treatment, or supportive care/no treatment) based on Comprehensive Geriatric Assessment (CGA) data, measured by the Area Under the Receiver Operating Characteristic Curve (AUC-ROC), with scores ranging from 0.5 (no discrimination/chance) to 1.0 (perfect discrimination).

Secondary outcomes

  1. Incidence of High-Grade Chemotherapy-Related Adverse Events

    Time frame: At 3 and 6 months post-enrollment.

    Percentage of participants experiencing Grade 3 or higher toxicities/adverse reactions evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  2. General Quality of Life Score (EORTC QLQ-C30)

    Time frame: Baseline, 3 months, and 6 months post-enrollment.

    Global health status and quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores range from 0 to 100, where higher scores represent a better overall quality of life and higher functioning.

  3. Elderly-Specific Quality of Life Score (EORTC QLQ-ELD14)

    Time frame: Baseline, 3 months, and 6 months post-enrollment.

    Elderly-specific quality of life issues assessed using the EORTC QLQ-ELD14 module. Scores range from 0 to 100. For symptom scales, higher scores represent worse outcomes (higher level of symptoms/problems); for functional scales, higher scores represent better outcomes.

  4. Incidence of Hospitalizations

    Time frame: At 3 and 6 months post-enrollment.

    Number of patients requiring unplanned hospital admissions during the treatment course

  5. Treatment Discontinuation and Dose Reduction Rates

    Time frame: At 3 and 6 months post-enrollment.

    Percentage of patients undergoing chemotherapy dose reductions (planned vs. received dose) or early treatment discontinuation.

  6. Patient Survival and Disease Progression

    Time frame: At 3 and 6 months post-enrollment.

    Overall survival status and disease progression rate assessed according to RECIST 1.0 criteria.

Study contacts

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

Head of Clinical Operations

CONTACT

[email protected]

+55 (51) 3384.5334

Project Manager

CONTACT

[email protected]

+55 51 3384 5334

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • ONCOGER SpA

Registry information

Official study title

PROgrama de Tamizaje y Evaluación oncoGERiátrica

Acronym: PROTEGER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 4, 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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