NCT06317389 PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments
| NCT ID | NCT06317389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2025-06-23 |
| Primary Completion | 2035-07 |
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 3,000 participants in total. It began in 2025-06-23 with a primary completion date of 2035-07.
⚠ 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
With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks. These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction, in life actual, dose-intensity and expected response. Furthermore, insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination, DRPs lead to an increase in the consumption of care. Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs. Set up in 2014 by the Hospices Civils de Lyon, this educational monitoring is based on a tripartite hospital intervention (oncologist, pharmacist, nurse) and a structured city-hospital link with private health professionals (attending doctor, community pharmacist and freelance nurse). Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities. The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population, on the real-life use of ATCO and on new methods of organizing ambulatory cancer care. The PACOME database collects sociodemographic, clinical and therapeutic data, and experiences in this population. Patients quality of life and other PROs (symptoms and adverse effects experienced by patients), social determinants, health care consumption, the caregiver-patient relationship, the use of digital technology in health, the organization of care, the city-hospital link (interventions of actors and their temporality). This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials, which are expected by health professionals and decision-makers. With patient data from the secure Oncoral pathway, PACOME brings together the three major and inseparable assets of real-life databases: quality, completeness and meaning of the data. It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies, which will contribute to the animation of the new ecosystem of real-life health data in oncology.
Eligibility Criteria
Inclusion Criteria: * aged over 18 * eligible for treatment with oral anticancer drug (ATCO) (excluding clinical trial) in a cancer indication and whose treatment with an oral anticancer drug is scheduled * follow-up in one of the following departments at Lyon-Sud hospital: pulmonology, dermatology, hematology, medical oncology, gastroenterology or radiotherapy. * without a major psychiatric disorder likely to hinder the progress of the study, in the opinion of the investigator * participant in the ONCORAL monitoring program * Not having opposed participating in the study Exclusion Criteria: * in an institution * under legal protection measure
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06317389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06317389 currently recruiting?
Yes, NCT06317389 is actively recruiting participants. Contact the research team at catherine.rioufol@chu-lyon.fr for enrollment information.
Where is the NCT06317389 trial being conducted?
This trial is being conducted at Pierre-Bénite, France.
Who is sponsoring the NCT06317389 clinical trial?
NCT06317389 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 3,000 participants.
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