Analyzing patient characteristics for advanced cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Miguel A Quintela, PhD — CNIO- Spanish Research Cancer Center
• Study coordinator: Miguel A Quintela, PhD
• Email: mquintela@cnio.es
• Phone: +34917328000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessing the safety and effectiveness of BC3195 in advanced cancer patients

  This study is testing a new drug called BC3195 to see if it is safe and effective for people with advanced cancer who haven't had success with other treatments.

  Recruiting Phase 1 Biocity Biopharmaceutics Co., Ltd. · Cleveland, Ohio · NCT06548672

• Evaluating AGX101 for advanced solid tumors

  This study is testing a new drug called AGX101 to see if it can help people with advanced solid tumors who haven't had success with other treatments.

  Recruiting at 7 sites Phase 1 Angiex, Inc. · Los Angeles, California and 6 other locations · NCT06440005

• Testing repotrectinib with chemotherapy for children and young adults with advanced solid tumors

  This study is testing if the drug repotrectinib, when combined with chemotherapy, can help children and young adults with advanced solid tumors feel better and improve their treatment outcomes.

  Recruiting Phase 1/2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT05004116

• Adding targeted GRID-style radiation to standard palliative therapy for unresectable solid tumors

  This study tests whether adding spatially fractionated radiation therapy to standard palliative radiation helps relieve symptoms in patients with unresectable solid tumors.

  Recruiting at 2 sites Mayo Clinic · Scottsdale, Arizona and 1 other locations · NCT07856394

• Concise coaching to guide decisions for advanced cancer patients considering palliative procedures

  A coaching program delivered by lay providers will test whether it helps adults with advanced cancer make better, patient-aligned decisions about palliative surgeries or similar interventions.

  Recruiting Singapore General Hospital · Singapore · NCT07789093

• BG-85738 alone or with other anticancer drugs in RAS-mutant advanced or metastatic solid tumors

  This study tests BG-85738, alone or with other cancer drugs, in adults whose solid tumors have RAS mutations and have progressed.

  Recruiting at 3 sites Phase 1 BeOne Medicines · South Brisbane, Queensland and 2 other locations · NCT07746141

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.