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

NCT06822959 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2026-03-12

No results posted yet for this 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.

Conditions

  • Adverse Drug Reaction (ADR)

Interventions

OTHER

Pharmacogenetics, TDM and MedReview

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

Sponsors & Collaborators

  • Centro di Riferimento Oncologico - Aviano

    collaborator OTHER

  • IRCCS Burlo Garofolo

    collaborator OTHER

  • Direzione centrale salute, politiche sociali e disabilità

    lead OTHER

Principal Investigators

  • Erika Cecchin · Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2025-12-31
Completion
2026-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06822959 on ClinicalTrials.gov