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

Overview

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.

Interventions

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

Primary outcome measures

• Solid cohort of clinical, analytical and epidemiological variables [Time frame: 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 outcome measures (12)

• Recorded heart rate [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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]
• Correlation Performance Status [Time frame: 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]
• Quality of life questionnaires: EORTC QLQ-C30, Goldberg-GHQ28, Mediterranean diet adherence questionnaire and PRO-CTCAE [Time frame: 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]
• Patients' physical routine [Time frame: 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]
• Correlation of physical activity and tolerance and response to treatment [Time frame: 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]
• Correlation of physiological adaptation to exercise and tolerance and response to treatment [Time frame: 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]
• Correlation tumor stage and tolerance and response to treatment [Time frame: 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]
• Correlation tumor origin and tolerance and response to treatment [Time frame: 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]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 9 centers

• Hospital Universitario A Coruña — A Coruña
• Hospital Universitario de Fuenlabrada — Fuenlabrada
• Hospital Son Espases — Palma de Mallorca
• Complejo Hospitalario de Navarra — Pamplona
• Hospital Virgen de la Macarena — Seville
• ICO Hospitalet Bellvitge — Barcelona
• Hospital San Pedro Alcántara de Cáceres — Cáceres
• Hospital de La Princesa — Madrid
• … and 1 more center

Identifiers

NCT: NCT06590506 · High Definition Medicine PMP22 · PMP22/00032

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗