Using genetics and drug monitoring to improve cancer treatment and reduce side effects
Pharmacogenetics, Therapeutic Drug Monitoring (TDM) and Active Pharmacovigilance as Innovative Tools Aimed at the Optimisation/ Appropriateness of Drug Therapy and the Minimisation of the Risks of ADRs in Clinical Practice: a Multidisciplinary Approach Exportable at National Level
This study is testing a new way to personalize cancer treatment using genetics and drug monitoring to see if it can help reduce side effects for adults with cancer and kids with chronic inflammatory diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Sex | All |
| Sponsor | Direzione centrale salute, politiche sociali e disabilità Academic / other |
| Drugs / interventions | Infliximab, Adalimumab, Imatinib, Sunitinib, Lenvatinib, Methotrexate, Cyclophosphamide |
| Locations | 2 sites (Aviano, Pordenone and 1 other locations) |
| Trial ID | NCT06822959 on ClinicalTrials.gov |
What this trial studies
This observational study aims to implement a multidisciplinary approach that combines pharmacogenetics, therapeutic drug monitoring (TDM), and active pharmacovigilance to optimize drug prescriptions and minimize adverse drug reactions (ADRs) in adult cancer patients and pediatric patients with chronic inflammatory diseases. By comparing the incidence of ADRs in patients treated with these innovative methods to historical cases treated with standard care, the study seeks to evaluate the effectiveness of this approach. Additionally, it aims to enhance the quality of ADR reporting through improved data integration into national pharmacovigilance systems.
Who should consider this trial
Good fit: Ideal candidates for this study include adult cancer patients and pediatric patients with chronic inflammatory diseases who are candidates for specific therapies such as Abemaciclib, Palbociclib, and others listed in the eligibility criteria.
Not a fit: Patients who are not candidates for the specified therapies or those with conditions unrelated to cancer or chronic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of adverse drug reactions and improve the appropriateness of drug therapy for patients.
How similar studies have performed: Other studies have shown success with similar pharmacogenetic and monitoring approaches, indicating potential for this innovative methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients who are candidates for therapy with: * Abemaciclib, * Palbociclib, * Ribociclib, * Letrozole, * Tamoxifen, * Olaparib, * Niraparib, * Rucaparib, * Imatinib, * Sunitinib, * Sorafenib, * Regorafenib, * Lenvatinib, * Irinotecan, * Capecitabine, * 5-Fluorouracil, * Infliximab, * Cyclophosphamide, * Methotrexate, * Adalimumab, * 6-Mercaptopurine/Azathioprine
Where this trial is running
Aviano, Pordenone and 1 other locations
- Centro di Riferimento Oncologico di Aviano (CRO) — Aviano, Pordenone, Italy (Recruiting)
- IRCCS materno infantile Burlo Garofolo di Trieste — Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Erika Cecchin — Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
- Study coordinator: Paola Rossi
- Email: paola.rossi@regione.fvg.it
- Phone: +39 040 3775581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.