Detection and monitoring of clonal haematopoiesis

  • Research type

    Research Database

  • IRAS ID

    352380

  • Contact name

    Catherine Cargo

  • Contact email

    catherine.cargo@nhs.net

  • Research summary

    Detection and monitoring of clonal haematopoiesis

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    25/NE/0133

  • Date of REC Opinion

    20 Aug 2025

  • REC opinion

    Further Information Favourable Opinion

  • Data collection arrangements

    Patients with CH will be diagnosed by their respective Specialist Integrated Haematological Malignancy Diagnostic Services (SiHMDS) and/or by testing performed by one of seven genomic laboratory hubs (GLH). Named representatives from each GLH will be responsible for identifying new patients and registering them onto the online database. No additional investigations or appointments will be needed above routine clinical care. The results will not alter the patient’s diagnosis or treatment decisions locally and these will continue to be made using current gold standard guidelines. It is essential that the database is fully inclusive and representative of the diverse population within England. As such it is a requirement that all CH patients are captured in the database and without explicit consent. Patients will be informed how their data will be used and given the option to dissent.
    Basic demographic information will be registered on the database online including date of Birth, NHS number, diagnosis and blood count results. Genomic results will be transferred to the database from genomics laboratory/clinician on a monthly basis. There will then be regular linkage to national databases for included patients to capture hospital attendances, cancer diagnoses and date and cause of death.

  • Research programme

    The database will capture all patients diagnosed with clonal haematopoiesis across England. Haematopoiesis is the process by which the body makes new blood cells beginning with a founding cell called a hematopoietic stem cell (HSC). Sometimes stem cells acquire an abnormality in their genetic make-up (mutation) which then gives rise to a population of related cells or a clone which all share the same mutation and this is termed clonal haematopoiesis (CH). CH can be detected in healthy individuals most commonly as people get older and over time clones can expand to the point that they impact on bone marrow function and can ultimately progress to a confirmed blood cancer, most commonly myeloid neoplasms (MN). Patients with CH have a much higher risk of developing a confirmed MN and have a worse life expectancy when compared to those without. CH may also cause an increase in other diseases such as heart and inflammatory diseases. The aim of this study is to capture all patients with CH and correlate this diagnosis with key clinical data overtime including the development of blood cancer and other diseases. This will provide an unrivalled dataset to help improve diagnosis and management of CH and MNs.

  • Research database title

    Detection and monitoring of clonal haematopoiesis

  • Establishment organisation

    Leeds Teaching Hospitals NHS Trust

  • Establishment organisation address

    St James's University Hospital, Beckett Street

    Leeds

    LS9 7TF