South East London Plasma Cell Disorders Registry

The South East London Plasma Cell Disorders Registry (SEL PCD Registry) is a research database collecting information on patients with a range of plasma cell disorders including:

• Myeloma, including smouldering myeloma
• Monoclonal gammopathies, including MGUS, MGRS, and MGCS
• AL amyloidosis
• POEMS syndrome
• Solitary plasmacytomas
• IgM neuropathy

The Registry is a collaborative project initiated by King’s Health Partners (King’s College Hospital and Guys and St Thomas’ Hospitals), and the Lewisham and Greenwich Trust. The information we gather is being made available for quality improvement audits and research studies.

Data summary

The Registry collects routine clinical data from existing patient records, without any additional procedures or data collection exercises for patients. Data collected include:

• Demographics: gender, month and year of birth, ethnicity, postcode sector
• Diagnostics: diagnosis and date, immunotyping, FISH, ISS/r-ISS stage, comorbidities
• Follow-up data: vital status and date, date of death (if any)
• Chemotherapy treatment events: start date, regimen name, cycles completed, reason for discontinuation
• Response and progression details: lab results and investigations at start of treatment, best response, and progression
• Other treatment details: radiotherapy, stem cell transplant, spinal surgery
• Toxicity details: date and grade of key toxicities per line of treatment

Consent and confidentiality

All patients with plasma cell disorders under the care of one of the participating sites are being invited to enrol in the registry. All eligible patients will be made aware of the Registry via an invitation letter or conversation with a clinician. They will then be invited to consent to data collection either remotely or at a routine appointment.

On enrolment all patient records are assigned a unique pseudonymised trial ID by PCS, our database software. In order to ensure patient confidentiality, this pseudonymised ID is the only way in which patients are identified within the Registry.

Registry governance

A Registry Oversight Committee meets twice yearly to review Registry activities. The Committee comprises Principal Investigators from each participating site alongside patient representatives, Information Governance experts, and other interested parties. The Committee’s responsibilities include:

• Monitoring data collection
• Tracking audit data requests and outcomes
• Reviewing and approving research data requests and tracking research outcomes
• Producing annual progress reports
• Overseeing public distribution of findings
• Reviewing and updating Registry procedures

Data use

All requests for data to complete audits and research studies are tracked, reviewed, and approved by the Registry Oversight Committee. Audits aimed at quality assurance and service improvement across one or more participating Trusts are required to meet the initiating Trusts’ standards of data protection and scientific rigour.

All research data requests are submitted via a standardised route utilising a data request form. This form provides the Oversight Committee with the information that they require to perform an initial assessment of the proposed research and either approve, deny, or request further clarifications. All proposed research projects are required to demonstrate orientation towards patient benefit, ensure potential ethical issues have been thought through and mitigated, and must display statistical / scientific viability of expected outcomes.

All patient data supplied to researchers is fully anonymised, and researchers must provide assurances that Registry data will not be treated in any way that risks re-identifying individual patients (e.g. by collating Registry records with other existing non-anonymised patient records).

For more detail please contact kch-tr.selpcdregistry@nhs.net.