Actively Recruiting
Prospective Clinical Evaluation of Incidence, Outcomes and Individual Experiences Following Diagnosis of Clonal Haematopoiesis in a Dedicated Research Clinic
Led by Clinical Hub for Interventional Research (CHOIR) · Updated on 2026-05-13
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Clinical Hub for Interventional Research (CHOIR)
Lead Sponsor
M
Medical Research Future Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on people aged 55 and older who have or may have clonal haematopoiesis (CH), a condition where a group of blood-forming stem cells with specific mutations grows abnormally. CH is common in older adults and can increase the risk of serious health issues like blood cancers, heart disease, and strokes. The study aims to better understand CH detection, outcomes, and patient experiences, helping to guide future care and research in Australia. Participants confirmed or suspected to have CH will be invited to a specialized clinic for molecular testing and monitoring. The study will establish a registry to track their health over time, with regular visits scheduled for assessments. These visits will include blood tests and evaluations to monitor for complications, quality of life, psychological well-being, and disease progression. The study also offers personalized support to participants based on their condition. During the study, participants will provide blood samples and health information at multiple visits over five years, starting with screening and continuing with follow-ups at weeks 6, 52, 104, 156, 208, and 260. Researchers will assess changes in blood cell markers, psychological distress, and participants' understanding of CH. The study will create a detailed database to help doctors improve CH care and support future research efforts.
CONDITIONS
Brief Title
CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older
- Confirmed clonal haematopoiesis (CH) or possible CH with persistent, non-severe low blood counts on at least two occasions, four months apart
- Willing and able to provide written informed consent before any study procedures
You will not qualify if you...
- Severe low blood counts defined as any of: ANC < 0.5 x10^9/L, hemoglobin < 80 g/L, or platelet count < 50 x10^9/L
- Marked trilineage low blood counts: ANC < 1.0 x10^9/L, hemoglobin < 110 g/L, and platelet count < 100 x10^9/L
- Marked bilineage low blood counts with two or more of: ANC < 1.0 x10^9/L, hemoglobin < 110 g/L, platelet count < 100 x10^9/L
- Individuals with possible CH meeting above severe criteria will be excluded from referral and managed urgently elsewhere unless no cause is found and approved by the study principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants with clonal haematopoiesis are observed over time to evaluate health outcomes and CH-associated complications.
Initial visit, second visit at 6 weeks, then follow-up visits at 52, 104, 156, 208, and 260 weeks
Trial Site Locations
Total: 1 location
1
Canberra Health Services
Canberra, Australian Capital Territory, Australia, 2605
Actively Recruiting
Research Team
M
Mark Polizzotto Professor
J
Jun Yen Ng Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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