Clinical trial NCT06590506: High Definition Medicine for Solid Tumors Oncology
Official title: High Definition Medicine: Establishment of a Cohort of Patients With Advanced Cancer for Prospective High-resolution Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Solid Tumor
Advanced Cancer
Keywords: Lung cancer metastatic disease any first line treatment
Colon cancer metastatic disease any first line treatment
Breast cancer luminal first line hormonal treatment + CDK4/6 inhibitor
Lead sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced incurable and metastatic disease selected with the aim of being able to carry out continuous follow-up from the beginning of the first line of treatment until death or withdrawal of consent; sensing that the duration of follow-up will be acceptable in relation to the life expectancy of these patients.

Purpose of bringing together a heterogeneous group of tumor stages (locally advanced and metastatic) and tumor origins (breast, colon, lung...) is to obtain data that is sufficiently broad and representative to allow the identification of common risk factors patients of different stages and tumor origins without initially assuming that the origin or stage is a determining factor when tolerating or responding to oncological treatment.

Brief summary: The present study aims to analyze different genetic, phenotypic, environmental, social and lifestyle characteristics of cancer patients who are going to start a first line of cancer treatment with palliative intent and their possible relationship with tumor response or tolerance to treatment. In this way, the aim is to identify a series of variables that allow a better selection of patients and oncological treatments.

Detailed description: The objective of this study is to obtain a cohort of patients with advanced cancer that is robust and large enough to study the nature and possible interrelation between these variables and their influence on the response and tolerance to treatment.

To do this, the investigators will rely on the first of the high-definition medicine strategies and evaluate the main health determinants of each individual.

This strategy will be use because by obtaining a personal baseline from a sufficiently large cohort of patients the investigators will be able to interrelate and identify those variables that have greater weight when it comes to obtaining a response or good tolerance to oncological treatment.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of oncological disease of solid origin, candidate for first-line treatment (TREATMENT VIRGIN FOR METASTIC DISEASE).
* Advanced tumor stage (III or IV) not a candidate for treatment with curative intent.
* Preference will be given to the following pathologies and sub-types:
* Women with hormone-positive, HER2-negative breast cancer who will receive a CDK4/6 inhibitor plus a hormone inhibitor. o Women with lung cancer of any subtype, candidates to receive first-line treatment.
* Women with colon cancer of any subtype, candidates to receive first-line treatment.
* Patients who are going to start treatment in a clinical trial are allowed, as long as the treatment is known (in other words, patients who participate in double-blind studies would not be candidates). There are no inclusion problems for patients who have different types of therapies within the trial as long as they are known (examples such as the following, but not limited to these: women starting treatment for breast cancer with a SERD and an approved CDK4/6 inhibitor , women who start an AI and an experimental CDK4/6/2, women who start a triplet for breast cancer but include AI+CDK4/6i, women who start a triplet for lung cancer with chemotherapy, pembrolizumab, and an experimental immunotherapy , etc).
* ECOG performance status \<2.
* Sufficient capacity and knowledge to carry and use the wearable.
* Have a mobile device with internet access and an email account.
* Ability to complete quality of life, nutrition and mental health questionnaires.
* Written informed consent to participate in the trial obtained prior to any study-specific screening procedures.
* Patients with co-morbidities are not excluded - they are part of the "real world" clinic and it is necessary to know their evolution.
* For the same reason, pregnant women are not excluded.

Exclusion Criteria:

* Having previously received oncological treatment for metastatic disease or with palliative intent.
* Planned participation in treatment in a double-blind trial regime.
* Previous or concomitant malignant disease of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or cervical cancer in situ are eligible for the study.
* Concurrent illnesses that may significantly interfere with participation in the study at the discretion of the investigator. No specific diseases are specified, since patients with multiple pathologies are part of the daily clinic and it is very interesting to collect data from patients with other comorbidities, as long as they have the necessary digital familiarization to wear the wearable and use the APP.
* Carriers of therapeutic electronic devices: pacemakers, defibrillators or cardiac resynchronizers (due to potential interference caused by the device).

Primary outcomes:
measure: Solid cohort of clinical, analytical and epidemiological variables
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Secondary outcomes:
measure: Recorded heart rate
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Recorded oxygen saturation
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Recorded physical activity: number daily steps, distance traveled, number steps climbed, and time of physical activity
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Recorded daily sleep time and quality
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Adherence to wearable
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Correlation Performance Status
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Quality of life questionnaires: EORTC QLQ-C30, Goldberg-GHQ28, Mediterranean diet adherence questionnaire and PRO-CTCAE
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Patients' physical routine
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Correlation of physical activity and tolerance and response to treatment
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Correlation of physiological adaptation to exercise and tolerance and response to treatment
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first assessed up to 36 months
measure: Correlation tumor stage and tolerance and response to treatment
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
measure: Correlation tumor origin and tolerance and response to treatment
timeFrame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Other outcomes:
Locations:
city: La Coruña
country: Spain
facility: Hospital Universitario A Coruña
state: A Coruña/ Galicia
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
state: Mallorca / Baleares
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
state: Sevilla/ Andalucia
city: Barcelona
country: Spain
facility: ICO Hospitalet Bellvitge
city: Cáceres
country: Spain
facility: Hospital San Pedro Alcántara de Cáceres
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Valencia
country: Spain
facility: Hospital General de Valencia
Study officials:
affiliation: CNIO- Spanish Research Cancer Center
name: Miguel A Quintela, PhD
role: PRINCIPAL_INVESTIGATOR
References: