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NCT Number: NCT06822959

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

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.

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Key information

Conditions

Adverse Drug Reaction (ADR) Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Riferimento Oncologico di Aviano (CRO), Aviano, Pordenone, Italy

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About this study

Primary aim of the study:

To implement the use of pharmacogenetics, TDM, and MedReview at the regional level supporting their utility through an observational approach to assess the effects of these innovative methods, already active in IRCCS, for the optimization of appropriate drug use and minimization of ADR risk in adult and pediatric oncology patients, as well as pediatric patients with chronic inflammatory diseases. Specifically, the aim is to evaluate the incidence of ADRs in patients treated based on pharmacogenetics, TDM, and MedReview compared to historical cases treated according to the standard of care before the implementation of the proposed innovative methodologies.

Secondary aims of the study:

  • To evaluate the "Causality Assessment" between ADR and drug based on the enhanced data quality deriving from the integration of pharmacogenetics, TDM and MedReview into the Pharmacovigilance report.
  • To propose the systematic integration of the results related to pharmacogenetics, TDM, and MedReview within the existing fields of the current ADR reporting form. This aims to develop a proposal for updating AIFA procedures related to the inclusion of this type of evidence-based information in the National Pharmacovigilance Network (RNF), with a potential update of the reporting form.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacogenetics, TDM and MedReview

Other

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

Primary outcomes

  1. Patients treated with study drugs tested with pharmacogenetic and TDM analysis

    Time frame: Up to 2 years

    Percentage of patients treated with study drugs tested with pharmacogenetic and TDM analysis on total patients treated

  2. MedReview reports

    Time frame: Up to 2 years

    Number of MedReview reports

  3. ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview

    Time frame: Up to 2 years

    Incidence of ADRs in the study cohorts

  4. Comparison of ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview and retrospective data

    Time frame: Up to 2 years

    Difference in incidence of ADRs in the prospective cohort will be tested against historical data with binomial test

Secondary outcomes

  1. Integration of pharmacogenetics, TDM and MedReview information in the existing tool for the evaluation of "Causality assessment" between ADR and specific drug

    Time frame: Up to 2 years

    Change of Causality Assessment. The change is evaluated as the number of "definite" and "probable" associations between ADRs and suspected drugs compared with historical data

  2. Proposal for updating the pharmacovigilance reporting forms including Pharmacogenetics, TDM and MedReview information in the National Network of Pharmacovigilance

    Time frame: Up to 2 years

    Frequencies of new reports sent to the National Pharmacovigilance Network, including pharmacogenetics, TDM, and drug interaction data

  3. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 v3

    Time frame: Up to 2 years

    The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients.

    The possible answers to the questionnaire range from a minimum value ("not at all") to a maximum value ("very much"). Higher values indicate a worse quality of life.

    Mean and standard deviation of scores at EORTC QLQ-C30 v3 questionnaire will be evaluated.

  4. Costs of ADRs management

    Time frame: Up to 2 years

    Median and interquartile range of costs

  5. Concordance between plasmatic concentration measured with conventional methods and with new methods such as Dried Blood Spot (DBS)

    Time frame: Up to 2 years

    Lin's correlation coefficient between plasmatic concentration and DBS estimation

  6. Correlation between pharmacogenetic profile and drug exposure (TDM)

    Time frame: Up to 2 years

    Difference in drug exposure measured as Cmin for different pharmacogenetic profiles

  7. Correlation between ADRs, TDM and pharmacogenetics analyses

    Time frame: Up to 2 years

    Frequencies of ADRs in different subgroups of patients defined by TDM and pharmacogenetic profiles

  8. Correlation between ADRs, TDM and pharmacogenetics analyses

    Time frame: Up to 2 years

    Frequencies of severe ADRs in different subgroups of patients defined by TDM and pharmacogenetic profiles

Sponsors and collaborators

Lead sponsor

Direzione centrale salute, politiche sociali e disabilità

Other

Collaborators

  • Centro di Riferimento Oncologico - Aviano
  • IRCCS Burlo Garofolo

Registry information

Official study title

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

Acronym: INTEGRATE

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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