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| ID | Type | Description | Link |
|---|---|---|---|
| PMP22/00032 | Other Grant/Funding Number | Instituto de salud Carlos III |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First line breast cancer metastatic subtype luminal | Women with hormone-positive, HER2-negative breast cancer who will receive CDK4/6 inhibitor plus hormone treatment. |
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| First line colon cancer metastatic | Women with colon cancer of any subtype, candidates to receive first-line treatment. |
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| First line lung cancer metastatic | Women with lung cancer of any subtype, candidates to receive first-line treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable | Device | Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recorded heart rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel A Quintela, PhD | Contact | +34917328000 | 2930 | mquintela@cnio.es |
| Berta Nasarre, Pharmacist | Contact | +34916006584 | bnasarre@ext.cnio.es |
| Name | Affiliation | Role |
|---|---|---|
| Miguel A Quintela, PhD | CNIO- Spanish Research Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario A Coruña | Recruiting | A Coruña | A Coruña/ Galicia | 15006 | Spain |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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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)
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Hospital Universitario de Fuenlabrada | Recruiting | Fuenlabrada | Madrid | 28942 | Spain |
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| Hospital Son Espases | Recruiting | Palma de Mallorca | Mallorca / Baleares | 07120 | Spain |
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| Complejo Hospitalario de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
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| Hospital Virgen de la Macarena | Recruiting | Seville | Sevilla/ Andalucia | 41009 | Spain |
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| ICO Hospitalet Bellvitge | Recruiting | Barcelona | 08908 | Spain |
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| Hospital San Pedro Alcántara de Cáceres | Recruiting | Cáceres | 10003 | Spain |
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| Hospital de La Princesa | Recruiting | Madrid | 28006 | Spain |
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| Hospital General de Valencia | Recruiting | Valencia | 46014 | Spain |
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