Adverse Drug Reaction (ADR)INTEGRATENCT06822959
The INTEGRATE Study: Integrated Pharmacogenetics, TDM and Active Pharmacovigilance as Innovative Tools for the Optimisation and Appropriateness of Drug Therapy
An observational study of Adverse Drug Reaction (ADR), run by Direzione centrale salute, politiche sociali e disabilità at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Reaction (ADR)
- What is being tested?
- Pharmacogenetics, TDM and MedReview
- How many people
- 450 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Jun 2022to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients who are candidates for therapy with:
- Abemaciclib,
- Palbociclib,
- Ribociclib,
- Letrozole,
- Tamoxifen,
Show all 22Show fewer
- Olaparib,
- Niraparib,
- Rucaparib,
- Imatinib,
- Sunitinib,
- Sorafenib,
- Regorafenib,
- Lenvatinib,
- Irinotecan,
- Capecitabine,
- 5-Fluorouracil,
- Infliximab,
- Cyclophosphamide,
- Methotrexate,
- Adalimumab,
- 6-Mercaptopurine/Azathioprine
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Centro di Riferimento Oncologico di Aviano (CRO)
Aviano, Pordenone, 33081
IRCCS materno infantile Burlo Garofolo di Trieste
Trieste, Trieste, 34137
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Adverse Drug Reaction (ADR)
- Being tested
- Pharmacogenetics, TDM and MedReview
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetics, TDM and MedReviewOther
Patients will undergo pharmacogenetics, TDM and MedReview analyses according to the study protocol
| Study group | Role | What they receive |
|---|---|---|
| Adult patients | Adult cancer patients Receives: Other: Pharmacogenetics, TDM and MedReview | |
| Pediatric patients | Pediatric patients with chronic inflammatory diseases Receives: Other: Pharmacogenetics, TDM and MedReview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years
MedReview reports
Number of MedReview reports
Measured: Up to 2 years
ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview
Incidence of ADRs in the study cohorts
Measured: 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
Measured: 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
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
Measured: Up to 2 years
Proposal for updating the pharmacovigilance reporting forms including Pharmacogenetics, TDM and MedReview information in the National Network of Pharmacovigilance
Frequencies of new reports sent to the National Pharmacovigilance Network, including pharmacogenetics, TDM, and drug interaction data
Measured: Up to 2 years
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 v3
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.
Measured: Up to 2 years
Costs of ADRs management
Median and interquartile range of costs
Measured: Up to 2 years
Concordance between plasmatic concentration measured with conventional methods and with new methods such as Dried Blood Spot (DBS)
Lin's correlation coefficient between plasmatic concentration and DBS estimation
Measured: Up to 2 years
Correlation between pharmacogenetic profile and drug exposure (TDM)
Difference in drug exposure measured as Cmin for different pharmacogenetic profiles
Measured: Up to 2 years
Correlation between ADRs, TDM and pharmacogenetics analyses
Frequencies of ADRs in different subgroups of patients defined by TDM and pharmacogenetic profiles
Measured: Up to 2 years
Correlation between ADRs, TDM and pharmacogenetics analyses
Frequencies of severe ADRs in different subgroups of patients defined by TDM and pharmacogenetic profiles
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start10 Jun 2022
- Primary completion31 Dec 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug Reaction (ADR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direzione centrale salute, politiche sociali e disabilità
- Sponsor type
- University, hospital or other
- Collaborators
- Centro di Riferimento Oncologico - Aviano, IRCCS Burlo Garofolo
- Responsible party
- Sponsor
- Investigators
- Erika Cecchin, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822959
- Sponsor's protocol ID
- CRO-2022-14
- Acronym
- INTEGRATE
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06822959
- Acronym / sponsor ID
- INTEGRATE / CRO-2022-14
- Conditions
- Adverse Drug Reaction (ADR)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Direzione centrale salute, politiche sociali e disabilitàUniversity, hospital or other
- Collaborators
- Centro di Riferimento Oncologico - Aviano, IRCCS Burlo Garofolo
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult patients | – | Other: Pharmacogenetics, TDM and MedReviewAdult cancer patients |
| Pediatric patients | – | Other: Pharmacogenetics, TDM and MedReviewPediatric patients with chronic inflammatory diseases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (22 listed)
- Abemaciclib,
- Palbociclib,
- Ribociclib,
- Letrozole,
- Tamoxifen,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetics, TDM and MedReviewPatients will undergo pharmacogenetics, TDM and MedReview analyses according to the study protocol | Other | Adult patients, Pediatric patients |
Primary outcome
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
MedReview reports
Time frame: Up to 2 years
Number of MedReview reports
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
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
8 secondary outcomes
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
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
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 v3
Time frame: Up to 2 years
Costs of ADRs management
Time frame: Up to 2 years
Concordance between plasmatic concentration measured with conventional methods and with new methods such as Dried Blood Spot (DBS)
Time frame: Up to 2 years
Correlation between pharmacogenetic profile and drug exposure (TDM)
Time frame: Up to 2 years
Correlation between ADRs, TDM and pharmacogenetics analyses
Time frame: Up to 2 years
Correlation between ADRs, TDM and pharmacogenetics analyses
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Cecchin principal investigator
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Reaction (ADR), run by Direzione centrale salute, politiche sociali e disabilità at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients treated with study drugs tested with pharmacogenetic and TDM analysis (time frame: Up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.