High Definition Medicine for Solid Tumors Oncology (HDM-PMP22)

September 11, 2024 updated by: Centro Nacional de Investigaciones Oncologicas CARLOS III

High Definition Medicine: Establishment of a Cohort of Patients With Advanced Cancer for Prospective High-resolution Follow-up

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Miguel A Quintela, PhD
  • Phone Number: 2930 +34917328000
  • Email: mquintela@cnio.es

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08908
      • Cáceres, Spain, 10003
      • Madrid, Spain, 28006
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General de Valencia
        • Contact:
          • Begoña Bermejo de las Heras, MD
        • Contact:
        • Principal Investigator:
          • Begoña Bermejo de las Heras, MD
    • A Coruña/ Galicia
      • La Coruña, A Coruña/ Galicia, Spain, 15006
        • Recruiting
        • Hospital Universitario A Coruna
        • Principal Investigator:
          • Rosario García Campelo, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Manuel Fernandez Bruno
        • Sub-Investigator:
          • Cristina Reboredo Rendo
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Recruiting
        • Hospital Universitario de Fuenlabrada
        • Contact:
          • Miguel A Quintela, PhD
          • Phone Number: 2930 +34-91.732.80.00
          • Email: mquintela@cnio.es
        • Contact:
        • Principal Investigator:
          • Miguel Quintela, PhD
        • Sub-Investigator:
          • Desirée Jiménez, MD
        • Sub-Investigator:
          • Juan Antonio Guerra, MD
        • Sub-Investigator:
          • Carmen Pantin, MD
        • Sub-Investigator:
          • Laura Rodríguez, MD
    • Mallorca / Baleares
      • Palma De Mallorca, Mallorca / Baleares, Spain, 07120
        • Recruiting
        • Hospital Son Espases
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josefa Terrasa, PhD
        • Sub-Investigator:
          • Aitor Azkarate, MD
        • Sub-Investigator:
          • Antonia Perelló, MD
    • Navarra
    • Sevilla/ Andalucia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
Other Names:
  • Vivosmart Garmin bracelet
First line colon cancer metastatic
Women with colon cancer of any subtype, candidates to receive first-line treatment.
Device: Wearable
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
Other Names:
  • Vivosmart Garmin bracelet
First line lung cancer metastatic
Women with lung cancer of any subtype, candidates to receive first-line treatment.
Device: Wearable
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
Other Names:
  • Vivosmart Garmin bracelet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The feasibility of collecting heart rate using activity bracelets (wareables)
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
The feasibility of collecting oxygen saturation using activity bracelets (wareables)
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

The feasibility of collecting physical activity using activity bracelets (wareables).

Average time of physical activity: It is the average time, measured in minutes, that the patient remains active. It is a variable that aims to show how long, on average, the individual is capable of maintaining continuous 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
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
The feasibility of collecting daily sleep using activity bracelets (wareables). It consists of measuring the hours of daily sleep and the duration of each of the sleep phases. Normal sleep consists of two phases that repeat cyclically: the non-REM (NREM) phase, defined as the non-rapid eye movement phase of sleep; and the REM phase or rapid eye movement sleep phase. Monitoring sleep hours and quality by analyzing vital signs during sleep can detect sleep abnormalities and their correlation with the patient's quality of life.
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
Evaluate the porcentage of patient who meet the adherence to wear wearable monitoring. Measure the time that the patient wears the wearable throughout the study 24 hours a day (with the exception of the times necessary to recharge the battery). The included patients must commit to wearing the wearable for the entire time established in the protocol to optimize their quality and the results obtained.
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

Correlation between the Performance Status determined by the clinician and the patient's daily activity level.

The activity tracker will record your step count for each day. The investigators will plot the average daily step count and 95% confidence interval over the entire study period. You will then study the change in step count trajectory during the study. A linear mixed model will be used to describe change over time..
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
Correlation between the quality of life reported by the patient through QLQ questionnaires (EORTC QLQ-C30, Goldberg-GHQ28, Mediterranean diet adherence questionnaire and PRO-CTCAE) and the data collected through wearables
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
Identify changes in patients' physical routine throughout the monitoring period: The activity tracker will record your step count for each day. The investigators will plot the average daily step count and 95% confidence interval over the entire study period. You will then study the change in step count trajectory during the study. A linear mixed model will be used to describe change over time.
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 between the patient's degree of physical activity and tolerance and response to treatment
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 between the patient's physiological adaptation to exercise and tolerance and response to treatment
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 between tumor stage and tolerance and response to treatment
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
Correlation between tumor origin and tolerance and response to treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Nacional de Investigaciones Oncologicas CARLOS III

Investigators

  • Principal Investigator: Miguel A Quintela, PhD, CNIO- Spanish Research Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Estimated)

September 11, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High Definition Medicine PMP22
  • PMP22/00032 (Other Grant/Funding Number: Instituto de salud Carlos III)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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