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

NCT06822959 | Active Not Recruiting

• 1 other identifier: CRO-2022-14
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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)

Outcome Measures

Primary Outcomes (4)

• Patients treated with study drugs tested with pharmacogenetic and TDM analysis

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

  Up to 2 years

• MedReview reports

  Number of MedReview reports

  Up to 2 years

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

  Incidence of ADRs in the study cohorts

  Up to 2 years

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

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

  Up to 2 years

Secondary Outcomes (8)

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

  Up to 2 years

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

  Up to 2 years

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

  Up to 2 years

• Costs of ADRs management

  Up to 2 years

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

  Up to 2 years

Study Arms (2)

Adult patients

Adult cancer patients

Other: Pharmacogenetics, TDM and MedReview

Pediatric patients

Pediatric patients with chronic inflammatory diseases

Other: Pharmacogenetics, TDM and MedReview

Interventions

Pharmacogenetics, TDM and MedReview OTHER

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

Adult patients; Pediatric patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidates for therapy with: Abemaciclib, Palbociclib, Ribociclib, Letrozole, Tamoxifen, Olaparib, Infliximab, Cyclophosphamide, Methotrexate, Irinotecan, Capecitabine, 5-Fluorouracil, Noraparib, Adalimumab, Imatinib, Regorafenib, Lenvatinib, Sorafenib, Sunitinib, Rucaparib, 6-MP/ Azathioprine

You may qualify if:

• Patients who are candidates for therapy with:
• Abemaciclib,
• Palbociclib,
• Ribociclib,
• Letrozole,
• Tamoxifen,
• Olaparib,
• Niraparib,
• Rucaparib,
• Imatinib,
• Sunitinib,
• Sorafenib,
• Regorafenib,
• Lenvatinib,
• Irinotecan,

Sponsors & Collaborators

• Direzione centrale salute, politiche sociali e disabilità: lead
• Centro di Riferimento Oncologico - Aviano: collaborator
• IRCCS Burlo Garofolo: collaborator

Study Sites (2)

Centro di Riferimento Oncologico di Aviano (CRO)

Aviano, Pordenone, 33081, Italy

Location

IRCCS materno infantile Burlo Garofolo di Trieste

Trieste, Trieste, 34137, Italy

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Erika Cecchin

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: June 10, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)