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Recruiting NCT07313059

CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research

Trial Parameters

Condition Clonal Hematopoiesis
Sponsor Clinical Hub for Interventional Research (CHOIR)
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 55 Years
Max Age N/A
Start Date 2026-03
Completion 2033-11

Brief 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 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: 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 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

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