An EQA Scheme for TPMT Activity and Thiopurine Metabolites

NCT02598908 | Unknown FDA Drug

• 1 other identifier: IRAS 194310
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• TPMT activity

  TPMT activity will be determined by participating laboratories

  5 years EQA scheme

Secondary Outcomes (1)

• Thiopurine metabolites

  5 years EQA scheme

Study Arms (2)

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.

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.

Diagnostic Test: Quality control - enzyme activity

Interventions

Quality control - enzyme activity DIAGNOSTIC_TEST

A blood sample will be collected from patients and staff donors, no more than twice per year.

NHS staff volunteer donors; SWBH outpatient donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead
• Birmingham Quality: collaborator

Study Sites (1)

Department of Biochemistry, City Hospital

Birmingham, West Midlands, United Kingdom

RECRUITING

Related Links

• Birmingham quality UK NEQAS
• SWBH Pathology laboratory

Biospecimen

Retention: SAMPLES WITHOUT DNA

Up to 60 mL of EDTA blood will be collected from each of the selected volunteers by trained phlebotomy staff at Sandwell or City hospitals and virology tested just prior to the sample distribution. Surplus blood from routine specimens analysed for 6TGN and 6MMPN will be selected on the basis of thiopurine metabolite concentrations of interest and volume of blood remaining.

Study Officials

• Jonathan Berg, FRCPath, MBA

  SWBH, Pathology director

  STUDY DIRECTOR

Central Study Contacts

Jonathan Berg, FRCPath, MBA

CONTACT

01215075353; jonathanberg@nhs.net

Jenna Waldron, FRCPath

CONTACT

01215075025; jenna.waldron@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Clinical Scientist

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 6, 2015
• Study Start: February 24, 2017
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)