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Oncogeriatric Screening and Evaluation Program

PROgrama de Tamizaje y Evaluación oncoGERiátrica

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07805642
Acronym
PROTEGER
Enrollment
412
Registered
2026-09-04
Start date
2026-09-01
Completion date
2027-07-01
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor Cancer

Keywords

Oncogeriatrics

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Latin American Cooperative Oncology Group
Lead SponsorOTHER
ONCOGER SpA
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Predictive Accuracy of the PROTEGER Machine Learning ModelUp 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

MeasureTime frameDescription
Incidence of High-Grade Chemotherapy-Related Adverse EventsAt 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.
General Quality of Life Score (EORTC QLQ-C30)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.
Elderly-Specific Quality of Life Score (EORTC QLQ-ELD14)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.
Incidence of HospitalizationsAt 3 and 6 months post-enrollment.Number of patients requiring unplanned hospital admissions during the treatment course
Treatment Discontinuation and Dose Reduction RatesAt 3 and 6 months post-enrollment.Percentage of patients undergoing chemotherapy dose reductions (planned vs. received dose) or early treatment discontinuation.
Patient Survival and Disease ProgressionAt 3 and 6 months post-enrollment.Overall survival status and disease progression rate assessed according to RECIST 1.0 criteria.

Countries

Brazil

Contacts

CONTACTProject Manager
lacog0325@lacog.group+55 51 3384 5334
CONTACTHead of Clinical Operations
laura.voelcker@lacog.group+55 (51) 3384.5334
PRINCIPAL_INVESTIGATORLuciola Pontes Leite de Barros

Hospital do Coração (HCOR)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026