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Clinical Trials in Australia / NCT07313059
Recruiting Observational

CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research

NCT07313059 · tracked via the Priya Life Science Australia tracker
Phase
Observational
Started
2026-03-20
Last updated
2026-05-13

Condition(s) studied

Clonal HematopoiesisCCUS Clonal Cytopenia of Undetermined SignificanceHematologic Disease and Disorders

Study 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

Sex
ALL
Min age
55 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Aged 55 years and above 2. 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 3. Provision of written informed consent prior to any study-related assessments or procedures being carried out. Exclusion Criteria: 1. Severe cytopenia as defined by one or more of the following: 1. ANC \< 0.5 x109/L 2. Hb \< 80 g/L 3. Platelet count \< 50 x 109/L 2. 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Canberra Health Services Canberra Australian Capital Territory Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07313059 on ClinicalTrials.gov ↗ ← All trials in Australia