Analyzing patient characteristics for advanced cancer treatment

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

This study looks at the personal and lifestyle factors of cancer patients starting their first treatment to see how these affect their response to the treatment.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III (Academic / other)
• Drugs / interventions: pembrolizumab, chemotherapy, immunotherapy
• Locations: 9 sites (A Coruña, A Coruña/ Galicia and 8 other locations)
• Trial ID: NCT06590506 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze various genetic, phenotypic, environmental, social, and lifestyle characteristics of cancer patients starting first-line palliative treatment for metastatic solid tumors. By establishing a robust cohort, the study seeks to identify key variables that influence treatment response and tolerance. The approach utilizes high-definition medicine strategies to gather personal baseline data, allowing for a better selection of patients and oncological treatments based on individual health determinants.

Who should consider this trial

Good fit: Ideal candidates include women with hormone-positive, HER2-negative breast cancer, lung cancer of any subtype, or colon cancer of any subtype who are starting first-line treatment.

Not a fit: Patients with curative intent treatment options or those participating in double-blind clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with advanced cancer.

How similar studies have performed: Other studies have shown promise in utilizing patient characteristics to tailor cancer treatments, suggesting this approach may yield beneficial insights.

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).

Where this trial is running

A Coruña, A Coruña/ Galicia and 8 other locations

• Hospital Universitario A Coruña — A Coruña, A Coruña/ Galicia, Spain (Recruiting)
• Hospital Universitario de Fuenlabrada — Fuenlabrada, Madrid, Spain (Recruiting)
• Hospital Son Espases — Palma de Mallorca, Mallorca / Baleares, Spain (Recruiting)
• Complejo Hospitalario de Navarra — Pamplona, Navarre, Spain (Recruiting)
• Hospital Virgen de la Macarena — Seville, Sevilla/ Andalucia, Spain (Recruiting)
• ICO Hospitalet Bellvitge — Barcelona, Spain (Recruiting)
• Hospital San Pedro Alcántara de Cáceres — Cáceres, Spain (Recruiting)
• Hospital de La Princesa — Madrid, Spain (Recruiting)
• Hospital General de Valencia — Valencia, Spain (Recruiting)

Study contacts

• Principal investigator: Miguel A Quintela, PhD — CNIO- Spanish Research Cancer Center
• Study coordinator: Miguel A Quintela, PhD

Conditions Metastatic Solid Tumor; Advanced Cancer; 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