Skip to content

CHAPTER: Clonal Haematopoiesis assessment: prevention, treatment, and research.

Prospective Clinical Evaluation of Incidence, Outcomes and Individuals Experiences following Diagnosis of Clonal Haematopoiesis in a Dedicated Research Clinic.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001373460
Acronym
CHAPTER
Enrollment
100
Registered
2025-12-09
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The researchers will see people with CH, or who may have CH. For people who may have CH, the researchers will organise testing to confirm the condition after providing counselling. People with CH who agree to participate in the study will also have monitoring of their CH, assessment of the risk of heart diseases, 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 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.

Interventions

After providing written informed consent, participants will be asked to: Provide peripheral blood samples for research purposes at screening (where required), Week 0, and then either annually, or biennially, thereafter alongside routine care samples. Complete 3 participant surveys during the study - Custom CH survey, the K6 scale and B-IPQ. The study surveys, questionnaires are paper based and the completion of these and review of information alongside them will take approximately 20 minutes

After providing written informed consent, participants will be asked to: Provide peripheral blood samples for research purposes at screening (where required), Week 0, and then either annually, or biennially, thereafter alongside routine care samples. Complete 3 participant surveys during the study - Custom CH survey, the K6 scale and B-IPQ. The study surveys, questionnaires are paper based and the completion of these and review of information alongside them will take approximately 20 minutes to read and fill out. These will be completed at screening, Week 6 and then either annually, or biennially, thereafter Participant health information and symptom directed physical exams will used to identify CH associated complications throughout the study at Week 0 and then either annually, or biennially, thereafter The period participants will be on this study will be approximately 5 years with study-related activities lining up with other clinical care and follow up.

Sponsors

Australian National University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
55 Years to No maximum
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: i. Absolute neutrophil count (ANC) < 1.8 x 10 9/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: a. ANC < 0.5 x10 9/L b. Hb < 80 g/L c. Platelet count < 50 x 10 9/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 3. Cytopenia attributed to other causes, including: a. Child-Pugh C cirrhosis b. Myelosuppressive medications c. Haematinic deficiencies d. Haematological malignancies e. Haemolytic anaemia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026