High Definition Medicine for Solid Tumors Oncology

NCT06590506 | Recruiting

• 2 other identifiers: High Definition Medicine PMP22PMP22/00032
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (1)

• Solid cohort of clinical, analytical and epidemiological variables

  To generate a large and solid cohort of clinical, analytical and epidemiological variables in patients with advanced cancer breast, lung and colon

  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 (12)

• Recorded heart rate

  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

• Recorded oxygen saturation

  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

• Recorded physical activity: number daily steps, distance traveled, number steps climbed, and time of physical activity

  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

• Recorded daily sleep time and quality

  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

• Adherence to wearable

  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

Study Arms (3)

First line breast cancer metastatic subtype luminal

Women with hormone-positive, HER2-negative breast cancer who will receive CDK4/6 inhibitor plus hormone treatment.

Device: Wearable

First line colon cancer metastatic

Women with colon cancer of any subtype, candidates to receive first-line treatment.

Device: Wearable

First line lung cancer metastatic

Women with lung cancer of any subtype, candidates to receive first-line treatment.

Device: Wearable

Interventions

Wearable DEVICE

Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)

Also known as: Vivosmart Garmin bracelet

First line breast cancer metastatic subtype luminal; First line colon cancer metastatic; First line lung cancer metastatic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centro Nacional de Investigaciones Oncologicas CARLOS III: lead

Study Sites (9)

Hospital Universitario A Coruña

A Coruña, A Coruña/ Galicia, 15006, Spain

RECRUITING

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

RECRUITING

Hospital Son Espases

Palma de Mallorca, Mallorca / Baleares, 07120, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Virgen de la Macarena

Seville, Sevilla/ Andalucia, 41009, Spain

RECRUITING

ICO Hospitalet Bellvitge

Barcelona, 08908, Spain

RECRUITING

Hospital San Pedro Alcántara de Cáceres

Cáceres, 10003, Spain

RECRUITING

Hospital de La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital General de Valencia

Valencia, 46014, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genetics: (tumor biopsy) NGS panel of 52 genes. Circulating nucleotides: (peripheral blood) circulating DNA. Epigenomics: (peripheral blood) changing the DNA sequence. Immunoma: (peripheral blood) level of lymphocytes including B, T, NK and CD45RO lymphocytes and macrophages as well as cytokines (IL-4, IL-5, IL-6, IL-10, IL-13 (anti-inflammatory), IL -2, IL-12 and IFN-ɣ (pro-inflammatory)). Metabolome: (peripheral blood) Proteome: (peripheral blood and tumor biopsy)

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Miguel A Quintela, PhD

  CNIO- Spanish Research Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel A Quintela, PhD

CONTACT

+34917328000; mquintela@cnio.es

Berta Nasarre, Pharmacist

CONTACT

+34916006584; bnasarre@ext.cnio.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: March 2, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (9)