Cancer Nutrition Study - A Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
NCT07804225
Immune-Related Adverse Events, Solid Tumor Cancer
View Trial DetailsNCT Number: NCT07805642
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Observational
BR192 HCOR - Hospital do Coração, São Paulo, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
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.
Time frame: At 3 and 6 months post-enrollment.
Number of patients requiring unplanned hospital admissions during the treatment course
Time frame: At 3 and 6 months post-enrollment.
Percentage of patients undergoing chemotherapy dose reductions (planned vs. received dose) or early treatment discontinuation.
Time frame: At 3 and 6 months post-enrollment.
Overall survival status and disease progression rate assessed according to RECIST 1.0 criteria.
Contact information is provided by the study sponsor or research team.
Head of Clinical Operations
CONTACT
Project Manager
CONTACT
Latin American Cooperative Oncology Group
Other
PROgrama de Tamizaje y Evaluación oncoGERiátrica
Acronym: PROTEGER
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.
Published trials that share one or more normalized conditions with this study.
NCT07804225
Immune-Related Adverse Events, Solid Tumor Cancer
View Trial DetailsNCT07743086
Solid Tumor Cancer
Detroit, Michigan, United States
View Trial DetailsNCT07685548
Adenocarcinoma, Carcinoma
View Trial DetailsNCT07664397
Advanced Solid Tumor, Bladder Cancer
San Francisco, California, United States
View Trial Details