Clonal haematopoiesis assessment and long-term monitoring for prevention and care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Canberra Health Services
  Canberra, Australian Capital Territory, Australia Recruiting

Study contacts

• Study coordinator: Mark Polizzotto Professor
• Email: mosaic.jcsmr@anu.edu.au
• Phone: +61000000000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.