NCT06590506 High Definition Medicine for Solid Tumors Oncology
| NCT ID | NCT06590506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro Nacional de Investigaciones Oncologicas CARLOS III |
| Condition | Metastatic Solid Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-03-02 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-03-02 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Miguel A Quintela, PhD
PRINCIPAL INVESTIGATOR
CNIO- Spanish Research Cancer Center
Frequently Asked Questions
Who can join the NCT06590506 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Metastatic Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06590506 currently recruiting?
Yes, NCT06590506 is actively recruiting participants. Contact the research team at mquintela@cnio.es for enrollment information.
Where is the NCT06590506 trial being conducted?
This trial is being conducted at A Coruña, Spain, Fuenlabrada, Spain, Palma de Mallorca, Spain, Pamplona, Spain and 5 additional locations.
Who is sponsoring the NCT06590506 clinical trial?
NCT06590506 is sponsored by Centro Nacional de Investigaciones Oncologicas CARLOS III. The principal investigator is Miguel A Quintela, PhD at CNIO- Spanish Research Cancer Center. The trial plans to enroll 300 participants.