RecruitingNCT07313059

CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research

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

Sponsor

Clinical Hub for Interventional Research (CHOIR)

Enrollment

100 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

Clonal Hematopoiesis Hematologic Disease and Disorders CCUS Clonal Cytopenia of Undetermined Significance

Summary

People identified to have CH or thought to have possible CH due to unexplained low blood cell counts, including low red blood cells, white blood cells, or platelets will be asked to take part in the study. Individuals who are confirmed to have CH and provide informed consent to participate in the study will have monitoring of their CH, assessment of the risk of heart diseases, blood cancers and personalised support. The researchers will also measure people's understanding of CH and how they feel after learning about CH. Researchers will then record the relevant information from people with CH in a central database over time to track long-term health outcomes. The information collected from the study will help create a blueprint for doctors to provide care for people with CH in the future, and guide further research into CH in Australia. Participants will be asked to donate blood samples for the study for research purposes including CH monitoring and testing and also provide health information for the central database.

Eligibility

Min Age: 55 Years

Inclusion Criteria4

Aged 55 years and above
Confirmed CH or possible CH, with possible CH defined by:
a. Persistent, non-severe cytopenia, characterised by one or more of the following, present on at least 2 occasions, at least 4 months apart: i. Absolute neutrophil count (ANC) \< 1.8 x 109/L ii. Haemoglobin (Hb) \< 115 g/L in females, \< 135 g/L in males iii. Platelet count \< 150 x 109/L
Provision of written informed consent prior to any study-related assessments or procedures being carried out.

Exclusion Criteria8

Severe cytopenia as defined by one or more of the following:
ANC \< 0.5 x109/L
Hb \< 80 g/L
Platelet count \< 50 x 109/L
Multilineage cytopenias:
a. Marked trilineage cytopenia with all the following present: i. ANC \< 1.0 x 109/L AND ii. Hb \< 110 g/L AND iii. Platelet count \< 100 x 109/L
b. Marked bilineage cytopenia, with two or more of the following present: i. ANC \< 1.0 x 109/L ii. Hb \< 110 g/L iii. Platelet count \< 100 x 109/L
Note: People with possible CH, with the above characteristics will be excluded from referral to the CH clinic and will instead have urgent investigation as an inpatient or in the haematology clinic. However, if no definite cause for cytopenia is identified, including CH, then individuals may be referred for CH screening at the CH clinic the discretion of the study PI

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