An EQA Scheme for TPMT Activity and Thiopurine Metabolites

External Quality Control Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598908
• Other study ID #: IRAS 194310
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2015
• Last updated: April 24, 2017
• Start date: February 24, 2017
• Est. completion date: February 24, 2022

Study information

• Verified date: April 2017
• Source: Sandwell & West Birmingham Hospitals NHS Trust
• Contact: Jonathan Berg, FRCPath, MBA
• Phone: 01215075353
• Email: jonathanberg[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• External Quality Control
• Thiopurine S-methyl Transferase (TPMT)

Intervention

Diagnostic Test:
• Quality control - enzyme activity
A blood sample will be collected from patients and staff donors, no more than twice per year.

Locations

Country	Name	City	State
United Kingdom	Department of Biochemistry, City Hospital	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
Sandwell & West Birmingham Hospitals NHS Trust	Birmingham Quality

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TPMT activity	TPMT activity will be determined by participating laboratories	5 years EQA scheme
Secondary	Thiopurine metabolites	Thiopurine metabolites will be determined by participating laboratories	5 years EQA scheme

External Links

•   Birmingham quality UK NEQAS
•   SWBH Pathology laboratory