External Quality ControlNCT02598908
An EQA Scheme for TPMT Activity and Thiopurine Metabolites
An observational study of External Quality Control and Thiopurine S-methyl Transferase (TPMT), run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Participation in EQA schemes, where available, is mandatory for the United Kingdom Accreditation Service (UKAS). No EQA scheme currently exists for TPMT and thiopurine metabolites, which is a potential shortcoming of these tests. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- External Quality Control, Thiopurine S-methyl Transferase (TPMT)
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2017to 24 Feb 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Interested staff working within the Pathology Department at SWBH NHS Trust A list of SWBH NHS Trust patient TPMT results will be gathered from the Pathology computer system. Those with a TPMT activity of interest, measured in the past five years, will be contacted with the agreement of their hospital consultant.
Who may be able to join
- Pathology staff member - able to donate 60 mL of venous blood.
- SWBH NHS Trust outpatients - have had TPMT activity measured within last 5 years. Consultant happy for them to be contacted. Able to consent and donate 60 mL of blood.
- No known Hep B or C, HIV, syphilis or cytomegalovirus infection.
Who cannot join
- Donors for each distribution will be under no obligation to participate if they are no longer willing to. Only volunteers able to give informed consent themselves will be recruited (i.e. no children or adults lacking the capacity to consent themselves).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Biochemistry, City Hospital
Birmingham, West Midlands
Jonathan Berg, FRCPath, 01215075345, jonathanberg@nhs.net
Jenna Waldron, FRCPath, 01215075025, jenna.waldron@nhs.net
About this study
Official title: Collection of Blood Samples for Use in an External Quality Assurance (EQA) Scheme for Thiopurine S-methyl Transferase (TPMT) Activity and Thiopurine Metabolites, 6-thioguanine Nucleotides (6TGN) and 6-methyl Mercaptopurine Nucleotides (6MMPN).
Participation in EQA schemes, where available, is mandatory for the United Kingdom Accreditation Service (UKAS). No EQA scheme currently exists for TPMT and thiopurine metabolites, which is a potential shortcoming of these tests. A pilot of this project has been awarded funding by Clinical Pathology Accreditation (CPA).
The purpose of this work is to collect samples for an EQA scheme for whole blood TPMT (activity and genotype) and thiopurine metabolites, which will be run in collaboration with UK NEQAS (United Kingdom National External Quality Assessment Service), and facilitate a comprehensive world-wide service that enables laboratories providing these tests to fulfil quality goals and ultimately provide optimal patient care.
Read the detailed description
The thiopurine S-methyl transferase (TPMT) enzyme is involved in the breakdown of thiopurine drugs (such as azathioprine), which are commonly used to treat inflammatory bowel disease and autoimmune diseases. Different individuals in the population have different, genetically determined, levels of TPMT. An individual with absent TPMT activity has a high risk of serious side effects from thiopurine drug treatment. In routine practice, TPMT activity in the blood is measured before starting patients on thiopurine drugs to determine an effective and safe starting dose.
Thiopurine metabolites are the breakdown products of thiopurine drugs and are monitored in the blood of patients on thiopurine drugs to optimise their drug dose.
These tests are performed by laboratories across Britain and around the world. It is important for patient care that the results are of high quality and consistent across different centres. One way of assessing this is through an EQA scheme. No EQA scheme currently exists for TPMT/thiopurine metabolites, which is a potential shortcoming of the tests.
Venous blood collected from NHS staff volunteers and SWBH outpatients, who have had TPMT measured as part of their routine care, will be distributed to participating laboratories every two months. Where it is not possible to find suitable blood donors, pooled surplus blood samples from the laboratory will be used instead. The laboratories will test the samples and return results to UK NEQAS for comparison. A report will be compiled allowing them to compare themselves with other centres and make changes where necessary.
- Being tested
- Quality control - enzyme activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality control - enzyme activityDiagnostic test
A blood sample will be collected from patients and staff donors, no more than twice per year.
| Study group | Role | What they receive |
|---|---|---|
| NHS staff volunteer donors | Interested staff working within the Pathology Department at SWBH NHS Trust will be provided with written information regarding the proposed EQA scheme and the sample collection procedure. A consent form will be given to staff members, who will be asked to return the signed form within 1 week if they wish to participate. Each participating staff member will be assigned a unique patient identifier to allow for sample results to be anonymised. Receives: Diagnostic Test: Quality control - enzyme activity | |
| SWBH outpatient donors | A list of SWBH NHS Trust patient TPMT results will be gathered from the Pathology computer system (Telepath). Those with a TPMT activity of interest, measured in the past five years, will be contacted with the agreement of their hospital consultant. Information and consent forms will be sent to the patient either through the post or via their hospital consultant. Each participating patient will be assigned a unique patient identifier to allow for sample results to be anonymised. Receives: Diagnostic Test: Quality control - enzyme activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
TPMT activity
TPMT activity will be determined by participating laboratories
Measured: 5 years EQA scheme
Secondary outcomes (1)
Thiopurine metabolites
Thiopurine metabolites will be determined by participating laboratories
Measured: 5 years EQA scheme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start24 Feb 2017
- Primary completion24 Feb 2022 (estimated)
- Study completion24 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Quality ControlStudies 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
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham Quality
- Responsible party
- Principal investigator, Jenna Waldron, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Jonathan Berg, FRCPath, MBA, Study director, SWBH, Pathology director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598908
- Sponsor's protocol ID
- IRAS 194310
- Status last verified
- Apr 2017
- First submitted
- 5 Nov 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. Results will be analysed anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood Samples for Use in an External Quality Assurance (EQA) Scheme for Thiopurine S-methyl Transferase (TPMT) Activity and Thiopurine Metabolites, 6-thioguanine Nucleotides (6TGN) and 6-methyl Mercaptopurine Nucleotides (6MMPN).
- ClinicalTrials.gov ID
- NCT02598908
- Acronym / sponsor ID
- IRAS 194310
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Birmingham Quality
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 24 Feb 2022 (estimated)
- Study completion
- 24 Feb 2022 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- 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.
Participation in EQA schemes, where available, is mandatory for the United Kingdom Accreditation Service (UKAS). No EQA scheme currently exists for TPMT and thiopurine metabolites, which is a potential shortcoming of these tests. A pilot of this project has been awarded funding by Clinical Pathology Accreditation (CPA).
The purpose of this work is to collect samples for an EQA scheme for whole blood TPMT (activity and genotype) and thiopurine metabolites, which will be run in collaboration with UK NEQAS (United Kingdom National External Quality Assessment Service), and facilitate a comprehensive world-wide service that enables laboratories providing these tests to fulfil quality goals and ultimately provide optimal patient care.
Detailed description
The thiopurine S-methyl transferase (TPMT) enzyme is involved in the breakdown of thiopurine drugs (such as azathioprine), which are commonly used to treat inflammatory bowel disease and autoimmune diseases. Different individuals in the population have different, genetically determined, levels of TPMT. An individual with absent TPMT activity has a high risk of serious side effects from thiopurine drug treatment. In routine practice, TPMT activity in the blood is measured before starting patients on thiopurine drugs to determine an effective and safe starting dose.
Thiopurine metabolites are the breakdown products of thiopurine drugs and are monitored in the blood of patients on thiopurine drugs to optimise their drug dose.
These tests are performed by laboratories across Britain and around the world. It is important for patient care that the results are of high quality and consistent across different centres. One way of assessing this is through an EQA scheme. No EQA scheme currently exists for TPMT/thiopurine metabolites, which is a potential shortcoming of the tests.
Venous blood collected from NHS staff volunteers and SWBH outpatients, who have had TPMT measured as part of their routine care, will be distributed to participating laboratories every two months. Where it is not possible to find suitable blood donors, pooled surplus blood samples from the laboratory will be used instead. The laboratories will test the samples and return results to UK NEQAS for comparison. A report will be compiled allowing them to compare themselves with other centres and make changes where necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NHS staff volunteer donors | – | Diagnostic Test: Quality control - enzyme activityInterested staff working within the Pathology Department at SWBH NHS Trust will be provided with written information regarding the proposed EQA scheme and the sample collection procedure. A consent form will be given to staff members, who will be asked to return the signed form within 1 week if they wish to participate. Each participating staff member will be assigned a unique patient identifier to allow for sample results to be anonymised. |
| SWBH outpatient donors | – | Diagnostic Test: Quality control - enzyme activityA list of SWBH NHS Trust patient TPMT results will be gathered from the Pathology computer system (Telepath). Those with a TPMT activity of interest, measured in the past five years, will be contacted with the agreement of their hospital consultant. Information and consent forms will be sent to the patient either through the post or via their hospital consultant. Each participating patient will be assigned a unique patient identifier to allow for sample results to be anonymised. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Interested staff working within the Pathology Department at SWBH NHS Trust A list of SWBH NHS Trust patient TPMT results will be gathered from the Pathology computer system. Those with a TPMT activity of interest, measured in the past five years, will be contacted with the agreement of their hospital consultant.
Key inclusion criteria (3 listed)
- Pathology staff member - able to donate 60 mL of venous blood.
- SWBH NHS Trust outpatients - have had TPMT activity measured within last 5 years. Consultant happy for them to be contacted. Able to consent and donate 60 mL of blood.
- No known Hep B or C, HIV, syphilis or cytomegalovirus infection.
Key exclusion criteria (1 listed)
- Donors for each distribution will be under no obligation to participate if they are no longer willing to. Only volunteers able to give informed consent themselves will be recruited (i.e. no children or adults lacking the capacity to consent themselves).
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 |
|---|---|---|
| Quality control - enzyme activityA blood sample will be collected from patients and staff donors, no more than twice per year. | Diagnostic test | NHS staff volunteer donors, SWBH outpatient donors |
Primary outcome
TPMT activity
Time frame: 5 years EQA scheme
TPMT activity will be determined by participating laboratories
1 secondary outcome
Thiopurine metabolites
Time frame: 5 years EQA scheme
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Birmingham quality UK NEQASLink provided by the sponsor.
- SWBH Pathology laboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not applicable. Results will be analysed anonymised.
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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.
Jonathan Berg, FRCPath, MBA study director
SWBH, Pathology director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of External Quality Control and Thiopurine S-methyl Transferase (TPMT), run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Berg, FRCPath, MBA (01215075353, jonathanberg@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TPMT activity (time frame: 5 years EQA scheme). 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 25 Apr 2017.