Metastatic Solid TumorHDM-PMP22NCT06590506
High Definition Medicine for Solid Tumors Oncology
An observational study of Metastatic Solid Tumor and Advanced Cancer, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 9 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Solid Tumor, Advanced Cancer
- What is being tested?
- Wearable
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 9 sitesSpain
- Study dates
- 2 Mar 2023to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Show all 13Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Spain9 sites, 9 recruiting
- Recruiting
Hospital Universitario A Coruña
A Coruña, A Coruña/ Galicia, 15006
Rosario Garcia Campelo, MD, ma.rosario.garcia.campelo@sergas.es
Sabela Varela, 981178000 ext. 292872, Sabela.Varela.Rodriguez@sergas.es
- Recruiting
ICO Hospitalet Bellvitge
Barcelona, 08908
Sonia Pernas, PhD, spernas@iconcologia.net
Mario Rodriguez, 932607746 ext. 3338, mrodriguezp@idibell.cat
- Recruiting
Hospital San Pedro Alcántara de Cáceres
Cáceres, 10003
Santiago Gonzalez, MD, santiago.gonzalez@salud-juntaex.es
Julia Cruces, 34 927256406, julia.crucesgonzalez@externos.salud-juntaex.es
- Recruiting
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Miguel A Quintela, PhD, +34-91.732.80.00 ext. 2930, mquintela@cnio.es
Berta Nasarre, +34-91.600.65.84, bnasarre@ext.cnio.es
- Recruiting
Hospital de La Princesa
Madrid, 28006
Ramón Colomer, PhD, +34.91.5202276, rcolomer@seom.org
Naila Dinia, Nurse, +34.91.5202276, oncologiamedica.princesa@outlook.com
- Recruiting
Hospital Son Espases
Palma de Mallorca, Mallorca / Baleares, 07120
Josefa Terrasa, PhD, josefa.terrasa@ssib.es
Laura Zamorano, 871 206130, Laura.zamorano@ssib.es
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Ruth Vera, PhD, ruth.vera.garcia@navarra.es
Amelia Bort, (34) 848 42 25 76, amelia.bort.carbonell@navarra.es
- Recruiting
Hospital Virgen de la Macarena
Seville, Sevilla/ Andalucia, 41009
David Vicente, PhD, david.vicente.sspa@juntadeandalucia.es
Elena Zaragoza, 608367061, elenazaragozavr@gmail.com
- Recruiting
Hospital General de Valencia
Valencia, 46014
Begoña Bermejo de las Heras, MD
Cristina Tebar, Nurse, ctebarincliva@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Solid Tumor, Advanced Cancer
- Being tested
- Wearable
- 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
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WearableDevice
Also called Vivosmart Garmin bracelet
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
| Study group | Role | What they receive |
|---|---|---|
| First line breast cancer metastatic subtype luminal | Women with hormone-positive, HER2-negative breast cancer who will receive CDK4/6 inhibitor plus hormone treatment. Receives: Device: Wearable | |
| First line colon cancer metastatic | Women with colon cancer of any subtype, candidates to receive first-line treatment. Receives: Device: Wearable | |
| First line lung cancer metastatic | Women with lung cancer of any subtype, candidates to receive first-line treatment. Receives: Device: Wearable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The feasibility of collecting heart rate using activity bracelets (wareables)
Measured: 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
The feasibility of collecting oxygen saturation using activity bracelets (wareables)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Mar 2023
- Primary completion30 Jan 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS III
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel A Quintela, PhD, Principal investigator, CNIO- Spanish Research Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590506
- Sponsor's protocol ID
- High Definition Medicine PMP22
- Other IDs
- PMP22/00032
- Acronym
- HDM-PMP22
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garma LD, Pernas S, Vicente Baz D, Garcia Campelo R, Terrasa J, Nasarre B, Vera Garcia R, Bermejo B, Gonzalez Santiago S, Fullana B, Rodriguez-Perez M, Fernandez Bruno M, Reboredo Rendo C, Perello A, Jimenez D, Guerra JA, Arrazubi V, de la Cruz S, Cejalvo JM, Tebar C, Nunez Berrueco E, Hernandez-Marin B, Rogado J, Olmos PM, Arbaizar LP, Villalba Oliva MA, Madrid Y, Sanz-Landaluze J, Moreno-Martin G, Morillas A, Lopez-Alonso A, Rodriguez-Paton A, Colomer R, Artes-Rodriguez A, Quintela-Fandino M. Longitudinal Clinical, Physiological, and Molecular Profiling of Female Patients With Metastatic Cancer: Protocol and Feasibility of a Multicenter High-Definition Oncology Study. JCO Precis Oncol. 2026 Sep;10(9):e2501185. doi: 10.1200/PO-25-01185. Epub 2026 Sep 17.
PubMed 42753220
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Medicine: Establishment of a Cohort of Patients With Advanced Cancer for Prospective High-resolution Follow-up
- ClinicalTrials.gov ID
- NCT06590506
- Acronym / sponsor ID
- HDM-PMP22 / High Definition Medicine PMP22
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS IIIUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First line breast cancer metastatic subtype luminal | – | Device: WearableWomen with hormone-positive, HER2-negative breast cancer who will receive CDK4/6 inhibitor plus hormone treatment. |
| First line colon cancer metastatic | – | Device: WearableWomen with colon cancer of any subtype, candidates to receive first-line treatment. |
| First line lung cancer metastatic | – | Device: WearableWomen with lung cancer of any subtype, candidates to receive first-line treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WearableAlso: Vivosmart Garmin braceletContinuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet) | Device | First line breast cancer metastatic subtype luminal, First line colon cancer metastatic, First line lung cancer metastatic |
Primary outcome
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42753220Garma LD, Pernas S, Vicente Baz D, Garcia Campelo R, Terrasa J, Nasarre B, Vera Garcia R, Bermejo B, Gonzalez Santiago S, Fullana B, Rodriguez-Perez M, Fernandez Bruno M, Reboredo Rendo C, Perello A, Jimenez D, Guerra JA, Arrazubi V, de la Cruz S, Cejalvo JM, Tebar C, Nunez Berrueco E, Hernandez-Marin B, Rogado J, Olmos PM, Arbaizar LP, Villalba Oliva MA, Madrid Y, Sanz-Landaluze J, Moreno-Martin G, Morillas A, Lopez-Alonso A, Rodriguez-Paton A, Colomer R, Artes-Rodriguez A, Quintela-Fandino M. Longitudinal Clinical, Physiological, and Molecular Profiling of Female Patients With Metastatic Cancer: Protocol and Feasibility of a Multicenter High-Definition Oncology Study. JCO Precis Oncol. 2026 Sep;10(9):e2501185. doi: 10.1200/PO-25-01185. Epub 2026 Sep 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miguel A Quintela, PhD principal investigator
CNIO- Spanish Research Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Solid Tumor and Advanced Cancer, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel A Quintela, PhD (+34917328000 ext. 2930, mquintela@cnio.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06590506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.