A registry-based study which will allow the evaluation participant outcomes and underpin clinical and translational studies in clonal haematopoiesis (CH).

 

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Prospective Clinical Evaluation of Incidence, Outcomes and Individuals Experiences following Diagnosis of Clonal Haematopoiesis in a Dedicated Research Clinic

NCT07313059  ANZCTR

CHAPTER Study

Project Status

Current

Indication

Clonal Haematopoiesis (CH)

Goal

The goal of this project is to establish a screening clinic and registry for participants with clonal haematopoiesis (CH).  CH is often asymptomatic and involves the clonal expansion of a population of hematopoietic stem cells in the absence of blood cancer. These expanded cells share an acquired ‘driver’ mutation and may be associated with dysplasia and/or cytopenia. 

CH is common in older adults, affecting 10-30% in people above 70 years of age.  It is also common in people living with HIV. The condition also increases the risk of multiple life-limiting complications, including myeloid neoplasms (MN), cardiovascular disease (CVD), cerebrovascular disease (CeVD). 

CH screening is not yet part of routine clinical practice, but it may improve the evaluation of individuals with unexplained cytopenia by identifying previously unrecognised CH. In the United States, specialised clinics now assess the impact of CH screening and offer multidisciplinary support from haematologists, with other specialists and allied health professionals. However, no comparable clinics currently exist in Australia. This study will inform the development of similar services in the ACT and more broadly across Australia.

There remains an urgent need for further research to address key knowledge gaps, including the value of CH screening and potential interventions. Although CH itself cannot yet be treated, early detection may help individuals make informed lifestyle choices, influence disease biology, and plan for risk management, surveillance and early detection of complications.

Method

Prospective longitudinal cohort study whereby participants will consent to screening for clonal haematopoiesis mutations in peripheral blood, related research testing and enrolment into an participant CH outcomes registry. Participants will attend a CH clinic for each visit and study related assessments, including annual or biennial follow up based on risk. 

CHOIR manages the clinical operations of the CHAPTER study and is currently collaborating with other researchers from Canberra Health Services (CHS), the Leukaemia and Blood Cancer Research Unit, University of Auckland, the Lowy Cancer Research Centre, University of New South Wales (UNSW) Sydney and The Australian National University (ANU).

The study is funded by the Medical Research Future Fund (MRFF).

This registry-based trial is being conducted over 8 years in in the ACT, with planned expansion to NSW sites.

Contact 

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Senior Trial Manager

Shiloh Middlemiss

Email: mosaic.jcsmr@anu.edu.au