Adverse Drug ReactionPREPARENCT03093818
PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions
A study testing Pharmacogenomic testing in people with Adverse Drug Reaction, run by J.J.Swen at 7 sites in 7 countries.
Trial summary
PREPARE is an international, prospective, multi-center, open, randomized, cross-over implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel of actionable pharmacogenomic variants, on adverse event incidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Reaction
- What is being tested?
- Pharmacogenomic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,950 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 20 Mar 2017to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 18 years old
- Subject must receive a first prescription (meaning no known prescription for this drug in the preceding 12 months) for one or more of 42 drugs, for which a Dutch Pharmacogenomic Working Group guideline is available, which is prescribed to them in routine care
- Subject is able and willing to take part and be followed-up for at least 12 weeks
- Subject is able to donate blood or saliva
- Subject has signed informed consent
- The study limit of enrolment (200 per arm, per 18-month block) for that drug has not been reached
Who cannot join
- Subject has previous (direct-to-consumer, or clinical) genetic testing for a gene important to the drug of inclusion
- Subject is pregnant or lactating
- Subject has a life expectancy estimated to be less than three months by treating clinical team
- Duration of the drug of inclusion total treatment length is planned to be less than seven consecutive days. A drug whose route of administration changes during the first seven days (e.g. intravenous to oral flucloxacillin) but whose total treatment duration is seven days or longer, is still eligible.
- For inpatients: hospital admission is expected to be less than 72 hours
- Subject is unable to consent to the study
Show all 13Show fewer
- Subject is unwilling to take part
- Subject has no fixed address
- Subject has no current general practitioner
- Subject is, in the opinion of the Investigator, not suitable to participate in the study
- Subject has existing impaired hepatic or renal function for which a lower dose or alternate drug selection are already part of current routine care. This would not apply to any drugs specifically given to manage liver/renal impairment/transplantation.
- Subject has an estimated glomerular filtration rate (MDRD) of less than 15 ml/min per 1,73m2 in a subject with a functioning graft
- Subject has advanced liver failure (stage Child-Pugh C)
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
PREPARE is an international, prospective, multi-center, open, randomized, cross-over implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes include, healthcare expenditure, process indicators for implementation and provider adoption of pharmacogenomics.
Read the detailed description
Pre-emptive pharmacogenomic testing will be implemented in clinical sites across seven European countries (United Kingdom, The Netherlands, Austria, Greece, Slovenia, Italy and Spain). The 36-month study is split into two (19 and 18-month) time-blocks. The participating countries are randomized to start with either implementing pharmacogenomics guided prescribing or with standard of care in the first block. In the pharmacogenomics guided prescribing arm, results of the pharmacogenomic test will be incorporated in the (electronic) medical record and may be used by physicians and pharmacists to guide drug and dose selection for 39 routinely prescribed drugs, as per the Dutch Pharmacogenomics Working Group guidelines. In the standard of care arm, patients will not receive pharmacogenomic testing. After this 19-month block, the countries switch to implementing the opposite strategy and will recruit new patients for a period of 18 months.
Patients are eligible for participation when they receive a first prescription for one or more of 39 drugs for which a Dutch Pharmacogenomic Working Group guideline is available (acenocoumarol, amitriptyline, aripiprazole, atomoxetine, atorvastatin, azathioprine ,capecitabine, citalopram, clomipramine, clopidogrel, codeine, doxepin, efavirenz, escitalopram, flecainide, flucloxacillin, fluorouracil, haloperidol, imipramine, irinotecan, mercaptopurine, metoprolol, nortryptiline, paroxetine, phenprocoumon, phenytoin, pimozide, propafenon, sertraline, simvastatin, tacrolimus, tamoxifen, tegafur, thioguanine, tramadol, venlafaxine, voriconazole, warfarin or zuclopenthixol). All patients will be followed for a minimum of three months and a maximum of 18 months. In total, 8,100 patients will be recruited; 4,050 will receive pharmacogenomic testing, and 4,050 will receive standard of care. Each implementation site will concentrate on, but is not limited to, recruiting patients within a specific therapeutic area. Therapeutic areas include primary care, general medicine, cardiology, oncology, psychiatry, neurology, and transplantation. It is hypothesized that implementing pharmacogenomics guided drug and dose selection will decrease incidence of clinically relevant adverse drug reactions by 30% (from 4% to 2.8% among those with actionable drug-gene interactions).
- Conditions
- Adverse Drug Reaction
- Being tested
- Pharmacogenomic testing
- 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.
Pharmacogenomic testingOther
The pharmacogenomic panel to be used incorporates 48 genetic variants for the following 13 "pharamacogenes": CYP2B6 (cytochrome P450), CYP2C19, CYP2C9, CYP2D6,CYP3A4, DPYD (dihydropyrimidine dehydrogenase), FVL (factor five Leiden), HLA-B (human leukocyte antigen), NUDT15 (Nudix hydrolase), SLCO1B1 (solute carrier organic anion transporter), TPMT (thiopurine methyltransferase), UGT1A1 (UDP-glucuronosyltransferase), and VKORC1 (vitamin K epoxide reductase complex).
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenomic testing arm | Experimental | 4,050 patients will provide a DNA sample. A pharmacogenomic test is performed. Results of this test are incorporated in the (electronic) medical record and combined with a clinical decision support system. Physicians and pharmacists may choose to use these results to guide drug and dose selection as per the Dutch Pharmacogenomics Working Group guidelines. Patients will receive a "Safety-Code card" containing their personal pharmacogenomics results, which can be used by other physicians or pharmacists during subsequent prescriptions. Receives: Other: Pharmacogenomic testing |
| Standard of care arm | No intervention | 4,050 patients will provide a DNA sample. However, no pharmacogenomic test is performed until the study is completed. Physicians and pharmacists will prescribe and dispense drugs routinely, without using pharmacogenomic test results to guide drug and dose selection. Patients will receive a mock "Safety-Code card", which does not contain personal pharmacogenomics results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a clinically relevant adverse drug reaction which is caused by the drug of inclusion. For oncology patients only hematological toxicities (grade 4-5) and non-hematological toxicities (grade 3-5) will be considered clinically relevant.
Defined as an adverse drug reaction which is causally related to the drug of inclusion (definite, probable or possible), clinically relevant (CTCAE Grade 2,3,4 or 5) and associated with a drug-genotype interaction (as per the Dutch Pharmacogenomics Working Group guidelines)
Measured: 12 weeks
Secondary outcomes (7)
Physician and pharmacist adherence to Dutch Pharmacogenomics Working Group guidelines
Defined as adhering to the guidelines or not adhering to the guidelines
Measured: 18 months
Healthcare expenditure related to adverse events
Any costs made as a result of an adverse event
Measured: 18 months
Incidence of drug discontinuation due to an adverse event
Related to the drug of inclusion
Measured: 18 months
Incidence of discontinuation due to lack of efficacy
Related to the drug of inclusion
Measured: 18 months
Quality of life
Time trade-off question
Measured: 18 months
Incidence of dose adjustments
Related to the drug of inclusion
Measured: 18 months
Attitudes towards and knowledge of pharmacogenomics
Composite outcome: a list of seven questions regarding pharmacogenomics
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start20 Mar 2017
- Primary completion30 Sep 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug ReactionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- J.J.Swen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, Medical University of Vienna, Centro di Riferimento Oncologico - Aviano, Andaluz Health Service, University of Patras, University of Ljubljana, Karolinska Institutet, The Golden Helix Foundation, Royal Dutch Pharmacists Association (KNMP), Bio.Logis Genetic Information Management, University Paul Sabatier of Toulouse, Uppsala University, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), Federal Institute for Drugs and Medical Devices, St. Antonius Hospital
- Responsible party
- Sponsor-investigator, J.J.Swen, Leiden University Medical Center
- Investigators
- Jesse J. Swen, PharmD PhD, Principal investigator, Leiden University Medical CenterMunir Pirmohamed, MB ChB(Hons) PhD, Principal investigator, University of LiverpoolGere Sunder-Plassmann, MD, Principal investigator, Medical University of ViennaGiuseppe Toffoli, MD, Principal investigator, Centro di Riferimento OncologicoCristina Lucía Dávila Fajardo, PharmD PhD, Principal investigator, Andaluz Health ServiceGeorge P. Patrinos, PhD, Principal investigator, University of PatrasVita Dolzan, MD PhD, Principal investigator, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093818
- Sponsor's protocol ID
- 668353 (U-PGx)
- Acronym
- PREPARE
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2017
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data management plan has been written to comply to FAIR principles. Findable: We will indicate the existence of the data in our scientific publications and at our website (www.upgx.eu). Accessible: The datasets will not be made openly accessible, but will become available upon request after publications of the main paper by the U-PGx consortium. Interoperable: We will make use of standardized scores and standardized methodologies for example the star allele nomenclature and rs-numbering for genetic variants. Reusable: We do not intend to licence our data. A data dictionary is available for the entire eCRF.
Publications
Habtemariam HD, Guchelaar HJ, Manson LEN, Swen JJ, Kant AC, Bohringer S. Reporting Adverse Drug Events: A Comparison of an Online Patient Tool Versus Telephone-Based Monitoring in Community Pharmacy Patients in the Netherlands. Drug Saf. 2025 Nov;48(11):1205-1214. doi: 10.1007/s40264-025-01571-4. Epub 2025 Jun 14.
PubMed 40517185Roncato R, Bignucolo A, Peruzzi E, Montico M, De Mattia E, Foltran L, Guardascione M, D'Andrea M, Favaretto A, Puglisi F, Swen JJ, Guchelaar HJ, Toffoli G, Cecchin E. Clinical Benefits and Utility of Pretherapeutic DPYD and UGT1A1 Testing in Gastrointestinal Cancer: A Secondary Analysis of the PREPARE Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2449441. doi: 10.1001/jamanetworkopen.2024.49441.
PubMed 39641926Swen JJ, van der Wouden CH, Manson LE, Abdullah-Koolmees H, Blagec K, Blagus T, Bohringer S, Cambon-Thomsen A, Cecchin E, Cheung KC, Deneer VH, Dupui M, Ingelman-Sundberg M, Jonsson S, Joefield-Roka C, Just KS, Karlsson MO, Konta L, Koopmann R, Kriek M, Lehr T, Mitropoulou C, Rial-Sebbag E, Rollinson V, Roncato R, Samwald M, Schaeffeler E, Skokou M, Schwab M, Steinberger D, Stingl JC, Tremmel R, Turner RM, van Rhenen MH, Davila Fajardo CL, Dolzan V, Patrinos GP, Pirmohamed M, Sunder-Plassmann G, Toffoli G, Guchelaar HJ; Ubiquitous Pharmacogenomics Consortium. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study. Lancet. 2023 Feb 4;401(10374):347-356. doi: 10.1016/S0140-6736(22)01841-4.
PubMed 36739136Psarias G, Iliopoulou E, Liopetas I, Tsironi A, Spanos D, Tsikrika A, Kalafatis K, Tarousi D, Varitis G, Koromina M, Siamoglou S, Patrinos GP. Development of Rapid Pharmacogenomic Testing Assay in a Mobile Molecular Biology Laboratory (2MoBiL). OMICS. 2020 Nov;24(11):660-666. doi: 10.1089/omi.2020.0168. Epub 2020 Oct 16.
PubMed 33064577
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions
- ClinicalTrials.gov ID
- NCT03093818
- Acronym / sponsor ID
- PREPARE / 668353 (U-PGx)
- Conditions
- Adverse Drug Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,950 participants (actual)
- Lead sponsor
- J.J.SwenUniversity, hospital or other
- Collaborators
- University of Liverpool, Medical University of Vienna, Centro di Riferimento Oncologico - Aviano, Andaluz Health Service, University of Patras, University of Ljubljana, Karolinska Institutet, The Golden Helix Foundation, Royal Dutch Pharmacists Association (KNMP), Bio.Logis Genetic Information Management, University Paul Sabatier of Toulouse, Uppsala University, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), Federal Institute for Drugs and Medical Devices, St. Antonius Hospital
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 28 Mar 2017 (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.
PREPARE is an international, prospective, multi-center, open, randomized, cross-over implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes include, healthcare expenditure, process indicators for implementation and provider adoption of pharmacogenomics.
Detailed description
Pre-emptive pharmacogenomic testing will be implemented in clinical sites across seven European countries (United Kingdom, The Netherlands, Austria, Greece, Slovenia, Italy and Spain). The 36-month study is split into two (19 and 18-month) time-blocks. The participating countries are randomized to start with either implementing pharmacogenomics guided prescribing or with standard of care in the first block. In the pharmacogenomics guided prescribing arm, results of the pharmacogenomic test will be incorporated in the (electronic) medical record and may be used by physicians and pharmacists to guide drug and dose selection for 39 routinely prescribed drugs, as per the Dutch Pharmacogenomics Working Group guidelines. In the standard of care arm, patients will not receive pharmacogenomic testing. After this 19-month block, the countries switch to implementing the opposite strategy and will recruit new patients for a period of 18 months.
Patients are eligible for participation when they receive a first prescription for one or more of 39 drugs for which a Dutch Pharmacogenomic Working Group guideline is available (acenocoumarol, amitriptyline, aripiprazole, atomoxetine, atorvastatin, azathioprine ,capecitabine, citalopram, clomipramine, clopidogrel, codeine, doxepin, efavirenz, escitalopram, flecainide, flucloxacillin, fluorouracil, haloperidol, imipramine, irinotecan, mercaptopurine, metoprolol, nortryptiline, paroxetine, phenprocoumon, phenytoin, pimozide, propafenon, sertraline, simvastatin, tacrolimus, tamoxifen, tegafur, thioguanine, tramadol, venlafaxine, voriconazole, warfarin or zuclopenthixol). All patients will be followed for a minimum of three months and a maximum of 18 months. In total, 8,100 patients will be recruited; 4,050 will receive pharmacogenomic testing, and 4,050 will receive standard of care. Each implementation site will concentrate on, but is not limited to, recruiting patients within a specific therapeutic area. Therapeutic areas include primary care, general medicine, cardiology, oncology, psychiatry, neurology, and transplantation. It is hypothesized that implementing pharmacogenomics guided drug and dose selection will decrease incidence of clinically relevant adverse drug reactions by 30% (from 4% to 2.8% among those with actionable drug-gene interactions).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenomic testing arm | Experimental | Other: Pharmacogenomic testing4,050 patients will provide a DNA sample. A pharmacogenomic test is performed. Results of this test are incorporated in the (electronic) medical record and combined with a clinical decision support system. Physicians and pharmacists may choose to use these results to guide drug and dose selection as per the Dutch Pharmacogenomics Working Group guidelines. Patients will receive a "Safety-Code card" containing their personal pharmacogenomics results, which can be used by other physicians or pharmacists during subsequent prescriptions. |
| Standard of care arm | No intervention | –4,050 patients will provide a DNA sample. However, no pharmacogenomic test is performed until the study is completed. Physicians and pharmacists will prescribe and dispense drugs routinely, without using pharmacogenomic test results to guide drug and dose selection. Patients will receive a mock "Safety-Code card", which does not contain personal pharmacogenomics results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be ≥ 18 years old
- Subject must receive a first prescription (meaning no known prescription for this drug in the preceding 12 months) for one or more of 42 drugs, for which a Dutch Pharmacogenomic Working Group guideline is available, which is prescribed to them in routine care
- Subject is able and willing to take part and be followed-up for at least 12 weeks
- Subject is able to donate blood or saliva
- Subject has signed informed consent
Key exclusion criteria (13 listed)
- Subject has previous (direct-to-consumer, or clinical) genetic testing for a gene important to the drug of inclusion
- Subject is pregnant or lactating
- Subject has a life expectancy estimated to be less than three months by treating clinical team
- Duration of the drug of inclusion total treatment length is planned to be less than seven consecutive days. A drug whose route of administration changes during the first seven days (e.g. intravenous to oral flucloxacillin) but whose total treatment duration is seven days or longer, is still eligible.
- For inpatients: hospital admission is expected to be less than 72 hours
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 |
|---|---|---|
| Pharmacogenomic testingThe pharmacogenomic panel to be used incorporates 48 genetic variants for the following 13 "pharamacogenes": CYP2B6 (cytochrome P450), CYP2C19, CYP2C9, CYP2D6,CYP3A4, DPYD (dihydropyrimidine dehydrogenase), FVL (factor five Leiden), HLA-B (human leukocyte antigen), NUDT15 (Nudix hydrolase), SLCO1B1 (solute carrier organic anion transporter), TPMT (thiopurine methyltransferase), UGT1A1 (UDP-glucuronosyltransferase), and VKORC1 (vitamin K epoxide reductase complex). | Other | Pharmacogenomic testing arm |
Primary outcome
Occurrence of a clinically relevant adverse drug reaction which is caused by the drug of inclusion. For oncology patients only hematological toxicities (grade 4-5) and non-hematological toxicities (grade 3-5) will be considered clinically relevant.
Time frame: 12 weeks
Defined as an adverse drug reaction which is causally related to the drug of inclusion (definite, probable or possible), clinically relevant (CTCAE Grade 2,3,4 or 5) and associated with a drug-genotype interaction (as per the Dutch Pharmacogenomics Working Group guidelines)
7 secondary outcomes
Physician and pharmacist adherence to Dutch Pharmacogenomics Working Group guidelines
Time frame: 18 months
Healthcare expenditure related to adverse events
Time frame: 18 months
Incidence of drug discontinuation due to an adverse event
Time frame: 18 months
Incidence of discontinuation due to lack of efficacy
Time frame: 18 months
Quality of life
Time frame: 18 months
Incidence of dose adjustments
Time frame: 18 months
Attitudes towards and knowledge of pharmacogenomics
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 40517185Habtemariam HD, Guchelaar HJ, Manson LEN, Swen JJ, Kant AC, Bohringer S. Reporting Adverse Drug Events: A Comparison of an Online Patient Tool Versus Telephone-Based Monitoring in Community Pharmacy Patients in the Netherlands. Drug Saf. 2025 Nov;48(11):1205-1214. doi: 10.1007/s40264-025-01571-4. Epub 2025 Jun 14.
- Derived from this study: PubMed 39641926Roncato R, Bignucolo A, Peruzzi E, Montico M, De Mattia E, Foltran L, Guardascione M, D'Andrea M, Favaretto A, Puglisi F, Swen JJ, Guchelaar HJ, Toffoli G, Cecchin E. Clinical Benefits and Utility of Pretherapeutic DPYD and UGT1A1 Testing in Gastrointestinal Cancer: A Secondary Analysis of the PREPARE Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2449441. doi: 10.1001/jamanetworkopen.2024.49441.
- Derived from this study: PubMed 36739136Swen JJ, van der Wouden CH, Manson LE, Abdullah-Koolmees H, Blagec K, Blagus T, Bohringer S, Cambon-Thomsen A, Cecchin E, Cheung KC, Deneer VH, Dupui M, Ingelman-Sundberg M, Jonsson S, Joefield-Roka C, Just KS, Karlsson MO, Konta L, Koopmann R, Kriek M, Lehr T, Mitropoulou C, Rial-Sebbag E, Rollinson V, Roncato R, Samwald M, Schaeffeler E, Skokou M, Schwab M, Steinberger D, Stingl JC, Tremmel R, Turner RM, van Rhenen MH, Davila Fajardo CL, Dolzan V, Patrinos GP, Pirmohamed M, Sunder-Plassmann G, Toffoli G, Guchelaar HJ; Ubiquitous Pharmacogenomics Consortium. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study. Lancet. 2023 Feb 4;401(10374):347-356. doi: 10.1016/S0140-6736(22)01841-4.
- Derived from this study: PubMed 33064577Psarias G, Iliopoulou E, Liopetas I, Tsironi A, Spanos D, Tsikrika A, Kalafatis K, Tarousi D, Varitis G, Koromina M, Siamoglou S, Patrinos GP. Development of Rapid Pharmacogenomic Testing Assay in a Mobile Molecular Biology Laboratory (2MoBiL). OMICS. 2020 Nov;24(11):660-666. doi: 10.1089/omi.2020.0168. Epub 2020 Oct 16.
- Ubiquitous Pharmacogenomics (U-PGx) Consortium Official WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data management plan has been written to comply to FAIR principles. Findable: We will indicate the existence of the data in our scientific publications and at our website (www.upgx.eu). Accessible: The datasets will not be made openly accessible, but will become available upon request after publications of the main paper by the U-PGx consortium. Interoperable: We will make use of standardized scores and standardized methodologies for example the star allele nomenclature and rs-numbering for genetic variants. Reusable: We do not intend to licence our data. A data dictionary is available for the entire eCRF.
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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.
Jesse J. Swen, PharmD PhD principal investigator
Leiden University Medical Center
Munir Pirmohamed, MB ChB(Hons) PhD principal investigator
University of Liverpool
Gere Sunder-Plassmann, MD principal investigator
Medical University of Vienna
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomic testing in people with Adverse Drug Reaction, run by J.J.Swen at 7 sites in 7 countries.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria, Greece, Italy, Netherlands, Slovenia and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of a clinically relevant adverse drug reaction which is caused by the drug of inclusion. For oncology patients only hematological toxicities (grade 4-5) and non-hematological toxicities (grade 3-5) will be considered clinically relevant. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093818, which also lists 4 linked publications.
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 19 Apr 2024.