CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research

NCT07313059 | Recruiting

• 1 other identifier: 24-CH-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Clonal Hematopoiesis; CCUS Clonal Cytopenia of Undetermined Significance; Hematologic Disease and Disorders

Keywords

Clonal Hematopoiesis; CH; CCUS

Outcome Measures

Primary Outcomes (1)

• Establishment of CH participant registry and characterisation of CH outcomes

  Through study completion, 5 years

Secondary Outcomes (7)

• Number and proportion of participants with CH in a population at risk

  Through study completion, 5 years

• Incidence of CH-associated complications

  First Visit (Week 0), Second Visit (Week 6) and Follow Up Visits (Weeks 52, 104, 156, 208 and 260)

• Number and proportion of participants with CH with good perception and quality of life

  At Screening, Second Visit (Week 6) and Follow Up Visits (Weeks 52, 104, 156, 208 and 260)

• Number and proportion of participants with CH with good understanding of the condition

  Screening, Second Visit (Week 6) and Follow Up Visits (Week 52, 104, 156, 208 and 260)

• Number and proportion of participants with CH experiencing psychological distress

  Screening, Second Visit (Week 6), Follow Up Visits (Week 52, 104, 156, 208, and 260)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals aged 55 years and over with confirmed CH (Group 1), and possible CH (Group 2) who meet the defined eligibility criteria. Around 100 participants will be recruited to the study.

You may qualify if:

• Aged 55 years and above
• 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
• Provision of written informed consent prior to any study-related assessments or procedures being carried out.

You may not qualify if:

• Severe cytopenia as defined by one or more of the following:
• ANC \< 0.5 x109/L
• Hb \< 80 g/L
• Platelet count \< 50 x 109/L
• 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

Sponsors & Collaborators

• Clinical Hub for Interventional Research (CHOIR): lead
• Medical Research Future Fund: collaborator
• Australian National University: collaborator
• University of Auckland, New Zealand: collaborator
• The Canberra Hospital: collaborator

Study Sites (1)

Canberra Health Services

Canberra, Australian Capital Territory, 2605, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood research samples will be collected. After research samples have been processed, analysed, and stored for study endpoint evaluation, as specified in this protocol, the remaining specimens, if any, at the University of Auckland, if necessary. However, there is no long term dedicated storage of participant research samples.

MeSH Terms

Conditions

Hematologic Diseases; Disease

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mark Polizzotto Professor

CONTACT

+61000000000; mosaic.jcsmr@anu.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 31, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2033
• Study Completion (Estimated): November 1, 2033
• Last Updated: March 23, 2026

Record last verified: 2025-12

Locations

AU (1)