Active — Not RecruitingNot Applicable

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

Italy450 participantsStarted 2022-06-10

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patients treated with study drugs tested with pharmacogenetic and TDM analysis

Timeframe: Up to 2 years

MedReview reports

Timeframe: Up to 2 years

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

Timeframe: Up to 2 years

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

Timeframe: Up to 2 years

Trial details

NCT IDNCT06822959

SponsorDirezione centrale salute, politiche sociali e disabilità

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Adverse Drug Reaction (ADR) trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patients treated with study drugs tested with pharmacogenetic and TDM analysis

Timeframe: Up to 2 years

MedReview reports

Timeframe: Up to 2 years

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

Timeframe: Up to 2 years

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

Timeframe: Up to 2 years