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NCT06590506Recruiting

High Definition Medicine for Solid Tumors Oncology

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
26 Aug 2024
Start date
2 Mar 2023
Primary completion date
30 Jan 2026
Lead sponsor
Centro Nacional de Investigaciones Oncologicas CARLOS III
Diseases
Lung cancer
NCT number
NCT06590506

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 2 Mar 2023 to the primary completion date, 30 Jan 2026
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Having previously received oncological treatment for metastatic disease or with palliative intent.
  • 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.

Other illness

  • Carriers of therapeutic electronic devices: pacemakers, defibrillators or cardiac resynchronizers (due to potential interference caused by the device).

Other

  • Planned participation in treatment in a double-blind trial regime.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario A Coruña
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A CoruñaSpainRecruiting
ICO Hospitalet Bellvitge
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BarcelonaSpainRecruiting
Hospital San Pedro Alcántara de Cáceres
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CáceresSpainRecruiting
Hospital Universitario de Fuenlabrada
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FuenlabradaSpainRecruiting
Hospital de La Princesa
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MadridSpainRecruiting
Hospital Son Espases
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Palma de MallorcaSpainRecruiting
Complejo Hospitalario de Navarra
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PamplonaSpainRecruiting
Hospital Virgen de la Macarena
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SevilleSpainRecruiting
Hospital General de Valencia
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ValenciaSpainRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.