Clonal haematopoiesis assessment and long-term monitoring for prevention and care
Prospective Clinical Evaluation of Incidence, Outcomes and Individuals Experiences Following Diagnosis of Clonal Haematopoiesis in a Dedicated Research Clinic
This project will follow people aged 55 and older who have clonal haematopoiesis or unexplained low blood counts to see how their blood changes over time and whether they develop heart disease or blood cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Clinical Hub for Interventional Research (CHOIR) Government |
| Locations | 1 site (Canberra, Australian Capital Territory) |
| Trial ID | NCT07313059 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort enrolling people aged 55+ with confirmed clonal haematopoiesis (CH) or possible CH defined by persistent, non-severe cytopenias. Participants will provide blood samples and clinical information over time to monitor CH clone dynamics, blood counts, cardiovascular risk factors, and early signs of myeloid neoplasms. The study will also measure participants' understanding and emotional response after learning about CH and offer personalised support and risk communication. Collected data will be entered into a central database to inform future clinical care pathways and research in Australia and collaborating sites.
Who should consider this trial
Good fit: Ideal candidates are people aged 55 or older with confirmed CH or persistent, non-severe unexplained cytopenias who can give informed consent and attend follow-up visits.
Not a fit: People with severe cytopenias or marked multilineage cytopenias, active haematologic malignancy, or those unable to attend required visits are unlikely to gain benefit from this observational monitoring.
Why it matters
Potential benefit: If successful, this work could enable earlier detection of blood cancers and cardiovascular complications and help doctors tailor monitoring and prevention plans for people with CH.
How similar studies have performed: Previous observational cohorts have consistently linked CH to higher risks of myeloid neoplasms and cardiovascular disease, but interventional strategies to change outcomes remain largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Canberra, Australian Capital Territory
- Canberra Health Services — Canberra, Australian Capital Territory, Australia (Recruiting)
Study contacts
- Study coordinator: Mark Polizzotto Professor
- Email: mosaic.jcsmr@anu.edu.au
- Phone: +61000000000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.