Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT06822959
Active, not recruiting Observational

The INTEGRATE Study: Integrated Pharmacogenetics, TDM and Active Pharmacovigilance as Innovative Tools for the Optimisation and Appropriateness of Drug Therapy

NCT06822959 · tracked via the Priya Life Science Italy tracker
Sponsor
Direzione centrale salute, politiche sociali e disabilità
Phase
Observational
Started
2022-06-10
Last updated
2026-03-12

Condition(s) studied

Adverse Drug Reaction (ADR)

Investigational drug(s) / intervention(s)

Pharmacogenetics, TDM and MedReview

Pharmacogenetics, TDM and MedReview: Patients will undergo pharmacogenetics, TDM and MedReview analyses according to the study protocol

Study summary

The primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, TDM (Therapeutic Drug Monitoring) and MedReview into the clinical practice in order to optimize the appropriateness of drugs prescription and to minimise the risk of Adverse Drug Reactions (ADRs) in adult cancer patients and in pediatric patients affected by chronic inflammatory diseases. This approach of active pharmacovigilance will also allow a better definition of the causality assessment of ADRs through the direct implementation of data quality in the reporting forms. The study may therefore constitute an example of an approach for both the prevention of ADRs and the optimization of drug use, and for the integration of pharmacogenetics, TDM, and the MedReview data into the National Pharmacovigilance Reports for an improved and innovative evaluation of adverse events, aiming at the implementation of this approach in the regional context.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Patients treated with study drugs tested with pharmacogenetic and TDM analysis — Up to 2 years
    Percentage of patients treated with study drugs tested with pharmacogenetic and TDM analysis on total patients treated
  • MedReview reports — Up to 2 years
    Number of MedReview reports
  • ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview — Up to 2 years
    Incidence of ADRs in the study cohorts
  • Comparison of ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview and retrospective data — Up to 2 years
    Difference in incidence of ADRs in the prospective cohort will be tested against historical data with binomial test

Trial sites (2)

FacilityCityRegionStatus
Centro di Riferimento Oncologico di Aviano (CRO) Aviano Pordenone
IRCCS materno infantile Burlo Garofolo di Trieste Trieste Trieste
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06822959 on ClinicalTrials.gov ↗ ← All trials in Italy