Development of a predictive model for treatment decision making in older people with cancer
| ISRCTN | ISRCTN11875539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11875539 |
- Submission date
- 14/08/2024
- Registration date
- 28/08/2024
- Last edited
- 28/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Cancer treatment involves an emotional and economic burden, with repercussions and costs that affect individuals, their families and communities, as well as the health system and the country as a whole, which is why the Government considers cancer as a social problem, creating a National Cancer Plan that considers a financial protection system for high-cost diagnoses and treatments. This shows the importance of the problem at the public policy level.
From this perspective, innovation can offer a solution to the current problem, which is why we propose to investigate, develop and validate the PROTEGER platform, through the research, development and validation of machine learning models in an unprecedented way worldwide to predict oncological treatments in older people with cancer with the design and development of the user experience, graphic interface, capable of being used by health users (doctor, nurse, technician, patient); and technically validate the PROTEGER software, capable of suggesting a 3-level onco-geriatric treatment recommendation (receives treatment, does not receive treatment or receives adjusted treatment).
Who can participate?
Elderly people (65 years and older) with a diagnosis of oncological pathology of solid tumour.
Presented to a local oncology committee or local oncology team and has a chemotherapy indication and in whom a Comprehensive Geriatric Assessment (CGA) is performed.
What does the study involve?
A group of geriatricians and oncologists from different public and private healthcare centres in Chile who are part of the research team will invite all older people with cancer who meet the inclusion criteria and received a CGA and were presented to an oncogeriatrics committee as part of their health care in the context of oncological treatment.
Older people who consciously and informedly agree to participate in the study will provide the data obtained from their CGA for this research.
At 3 and 6 months the treating doctor will follow up with the participant and will check the clinical record. Additionally, a telephone call will be made to the patient by a member of the research team, different from the treating physician, masked to the recommendation of the oncogeriatrics committee.
The information from the CGA, 3-month and 6-month follow-up will be recorded in a data recording platform for the researchers in charge of analyzing the information.
This information will help to develop, train and validate a predictive model with machine learning techniques to generate treatment recommendations to assist the decision-making of oncology teams according to the original indication of the oncogeriatrics committee, and design and develop an intuitive graphical interface for users (medical staff and patients) that allows data management and interpretation of analysis results.
What are the possible benefits and risks of participating?
The benefits are mainly for those with solid cancer who do not have access to an oncogeriatric committee and do not have the opportunity to get an expert recommendation about their cancer treatment.
Where is the study run from?
The study will run in different public and private centres in Chile
When is the study starting and how long is it expected to run for?
April 2024 to December 2025
Who is funding the study?
The cohort study follow-up does not have financial support
The development, training and validation of a predictive model with machine learning techniques is founded by CORFO CREA Y VALIDA (23CVC-245919) (Chile)
Who is the main contact?
Dr Gonzalo Navarrete
gnavarreteh@gmail.com
Contact information
Public, Scientific, Principal Investigator
999 Dr. Carlos Lorca Tobar Street
Santiago
8380456
Chile
 ORCID ID |
0000-0003-1221-9141 |
|---|---|
| Phone | +56 984798043 |
| gnavarrete@hcuch.cl |
Study information
| Study design | Multicentre mixed cohort (retrospective and prospective) study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | PROTEGER: PROgrama de Tamizaje y Evaluación oncoGERiátrica (Oncology Screening and Evaluation Program) |
| Study acronym | PROTEGER |
| Study objectives | The measurements obtained from the Comprehensive Geriatric Assessment (CGA) of older people with cancer and the decisions of an oncogeriatrics committee allow the development and training of a predictive model with machine learning techniques that provide treatment recommendations to assist the decision-making of oncology teams |
| Ethics approval(s) |
Approved 17/04/2024, Scientific or Research Ethics Committee of the Clinical Hospital of the University of Chile (999 Dr Carlos Lorca Tobar Street, Santiago de Chile, 8380456, Chile; +56 229789008; comiteetica@hcuch.cl), ref: 1417/24 |
| Health condition(s) or problem(s) studied | Older people with oncological pathology (solid tumor) |
| Intervention | Older people with oncological pathology will be recruited. All of them have received a comprehensive geriatric assessment at their respective centres and are presented to an oncogeriatrics committee. All patients who meet the eligibility criteria and gave informed consent to participate will be selected We will use their baseline characteristics, the results of their CGA, the clinical data related to the oncological treatment and the follow-up at 3 and 6 months for the exclusive purposes of this research for the development and validation of a predictive model with machine learning techniques. |
| Intervention type | Other |
| Primary outcome measure | The Machine Learning model performance will be evaluated with the Area Under Receiver Operating Characteristic Curve (AUC) compared to the decision of the Oncogeriatric team (no treatment, adjusted treatment, standard treatment). |
| Secondary outcome measures | 3 and 6 months of follow up after the decision of the oncogeriatrics committee: 1. Longitudinal analysis of the patient quality of life measured using EORTC-QLQ-C30 2. Consultations to the Emergency Department and Hospitalisations measured using patient records 3. Adverse drug reaction measured using patient records 4. Treatment withdrawal measured using patient records 5. Chemotherapy dose delay or dose reduction measured using patient records 6. Functionality (Basics and Instrumental activity daily living measured with the Barthel Index and the Pfeffer test). 7. The ECOG Performance Status Scale. 8. Cognitive impairment measure The Telephone Screening of Cognitive Status (TICS), IQCODE 9. Overall survival and progression-free survival analysed by Kaplan–Meier survival and measured from patient records |
| Overall study start date | 17/04/2024 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 110 Years |
| Sex | Both |
| Target number of participants | 412 |
| Key inclusion criteria | 1. People 65 years or older 2. Diagnosis of oncological pathology of solid tumours 3. The clinical case is presented to a local oncology committee or local oncology team 4. Patients in whom a CGA is performed |
| Key exclusion criteria | Patients who do not have the capacity or do not wish to consent to the delivery of information |
| Date of first enrolment | 01/06/2024 |
| Date of final enrolment | 31/05/2025 |
Locations
Countries of recruitment
- Chile
Study participating centres
Santiago de Chile
8380456
Chile
Santiago de Chile
8350488
Chile
Santiago de Chile
7500921
Chile
Temuco
4781151
Chile
Antofagasta
1240835
Chile
Sponsor information
Hospital/treatment centre
Clinical Research Support Office (Oficina de apoyo a la Investigación Clínica)
999 Dr Carlos Lorca Tobar Street
Santiago
8380456
Chile
| Phone | +56 229788535 |
|---|---|
| mnavarro@hcuch.cl | |
| Website | http://www.redclinica.cl/ |
"ROR" |
https://ror.org/02xtpdq88 |
Hospital/treatment centre
805 José Manuel Infante Street, Providencia
Santiago de Chile
7500921
Chile
| Phone | +56 24457266 |
|---|---|
| cec@falp.cl | |
| Website | https://www.falp.org |
|
"ROR" |
https://ror.org/03r4w0b84 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Corporation of Promotion of Production, Production Development Corporation, CORFO
- Location
- Chile
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Algorithmic transparency will be promoted through the declaration and publication of the entire development and validation process of the instrument in scientific journals with high methodological rigour and peer review. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request. Contact: Dr Gonzalo Navarrete Mail: gnavarreteh@gmail.com |
Editorial Notes
28/08/2024: Trial's existence confirmed by Scientific or Research Ethics Committee of the Clinical Hospital of the University of Chile.
