CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research

Recruiting now

Conditions studied: Clonal Hematopoiesis, CCUS Clonal Cytopenia of Undetermined Significance, Hematologic Disease and Disorders

In brief

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.

Key facts

Study ID

NCT07313059

Run by

Clinical Hub for Interventional Research (CHOIR)

People needed

100

Starts

2026-03-20

Expected to finish

2033-11-01

Last updated by the study team

2026-05-13

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (WHO criteria): i. Absolute neutrophil count (ANC) < 1.8 x 109/L ii. Haemoglobin (Hb) < 120 g/L in females, < 130 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.

You may not qualify if…

• 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

Where it is running

• Canberra Health Services — Canberra, Australian Capital Territory, Australia (enrolling)

Full record on ClinicalTrials.gov

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