Clonal HematopoiesisCHAPTERNCT07313059
CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research
An observational study of Clonal Hematopoiesis and CCUS Clonal Cytopenia of Undetermined Significance, run by Clinical Hub for Interventional Research (CHOIR) at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Clonal Hematopoiesis, CCUS Clonal Cytopenia of Undetermined Significance, Hematologic Disease and Disorders
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Mar 2026to Nov 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged 55 years and above
- Confirmed CH or possible CH, with possible CH defined by:
- 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
- Provision of written informed consent prior to any study-related assessments or procedures being carried out.
Who cannot join
- 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:
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jun Yen Ng Dr contact
Australia1 site, 1 recruiting
- Recruiting
Canberra Health Services
Canberra, Australian Capital Territory, 2605
Mark Polizzotto Professor, +61000000000, mosaic.jcsmr@anu.edu.au
Jun Yen Ng Dr, mosaic.jcsmr@anu.edu.au
About this study
Official title: Prospective Clinical Evaluation of Incidence, Outcomes and Individuals Experiences Following Diagnosis of Clonal Haematopoiesis in a Dedicated Research Clinic
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.
Read more
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.
Read the detailed description
Clonal Haematopoiesis (CH) refers to the clonal outgrowth of a population of hematopoietic stem cells in the absence of haematologic neoplasms. The clonal cells share an acquired 'driver' mutation., and the presence of dysplasia and/or cytopenia.
CH is common in older populations, with a frequency of 10-30% in people above 70 years of age.
Most individuals with CH are asymptomatic; however, the condition increases the risk of multiple life-limiting complications, including myeloid neoplasms (MN), cardiovascular disease (CVD), cerebrovascular disease (CeVD) by 11.1, 1.4, and 2-fold, respectively. While CH is not yet treatable, identifying the condition may assist individuals in making informed decisions, including an individualised management plan for early detection of CH-associated complications. CH screening is not currently performed in routine clinical practice.
The optimal approach to surveillance for myeloid neoplasms in individuals with CH remains undefined. Some individuals undergo active surveillance with regular blood count monitoring to detect early progression to MN. Early detection of MN may also broaden the therapeutic window for individuals. Additionally, this allows individuals to connect with suitable clinical trials.
CVD is the most common CH-associated complication; hence CV (cardiovascular) risk modification is important both from an individual and public health standpoint.
CH screening may also refine the evaluation of individuals with unexplained cytopenia, as they may have underlying CH that has not been identified.
Given the uncertainties surrounding the identification and management, dedicated research clinics have been developed in the United States to evaluate the impact of screening of CH. These clinics provide a supportive environment to discuss the condition and engage multidisciplinary management. In addition to haematologists, individuals are supported by other specialities and allied health professionals. However, dedicated CH clinics are not yet available in Australia.
There is an urgent need for more research into CH as there are crucial knowledge gaps. This includes the role of CH screening and interventions to modify the biology and risks of CH-associated complications. Given the widespread use of next-generation sequencing (NGS) panels in Australia, it is likely that CH will be increasingly identified in routine clinical practice, creating a pool of individuals who may benefit from counselling and follow-up in a dedicated service.
This cohort study will establish a screening clinic and a prospectively characterised registry of individuals with CH to serve as the basis for clinical and translational studies in CH.
With consent, individuals with possible CH will undergo screening by molecular testing in the first dedicated multidisciplinary CH clinic in Australia whereby the health outcomes of participants with CH can be evaluated.
- Conditions
- Clonal Hematopoiesis, CCUS Clonal Cytopenia of Undetermined Significance, Hematologic Disease and Disorders
- Keywords
- Clonal Hematopoiesis, CH, CCUS
- Medical subject headings
- Hematologic Diseases, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of CH participant registry and characterisation of CH outcomes
Measured: Through study completion, 5 years
Secondary outcomes (7)
Number and proportion of participants with CH in a population at risk
Measured: Through study completion, 5 years
Incidence of CH-associated complications
The incidence of CH-associated complications will be measured by:
- The number and proportion of participants with CH-associated complications (i.e., MN, CVD, CeVD, thrombosis) B) The number and proportion of participants with high CVD risk, as assessed using AusCVDRisk, and modification in individuals with CH C) The number of CV risk factors in participants with CH
Measured: 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
Individual's perception and understanding of CH changes over time will be measured and assessed using the Brief Illness Perception Questionnaire (B-IPQ)
Measured: 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
How an individuals' perception and understanding of CH changes over time will be measured using a custom CH survey
Measured: 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
The prevalence of psychological distress in individuals with CH will be measured using the Kessler Psychological Distress Scale (K6)
Measured: Screening, Second Visit (Week 6), Follow Up Visits (Week 52, 104, 156, 208, and 260)
Change in VAF in individuals with CH at different timepoints
The changes in the VAF (Variant Allele Fraction) in individuals with CH over time will be measured biennially (every 2 years) in all individuals.
DNA extracted from the peripheral blood will be sequenced after NGS library preparation and target-enrichment with a custom capture panel (Agilent Sure Select). Next Generation Sequencing (NGS) will be performed and the number of variant reads at a given position will be used to calculate the VAF. VAF will be a direct measure of the fraction of cells carrying the variant in the sample used for DNA extraction.
High Risk - CH participants will have additional VAF testing at Week 104 and Week 208 only if indicated i.e. worsening cytopenia, concerning blood film features or development of CH-associated complication.
Measured: Screening, Follow Up Visits (Week 52, 104, 156, 208 and 260)
Morphological changes by morphological feature analysis of CH changes
CH associated morphology changes on peripheral blood film appearance will be measured and analyzed using a computational method that detects and characterizes white and red blood cell features to identify CH-associated morphology features using deep learning approaches.
Images of stained and unstained peripheral blood films, and associated data reports, will be collected from each participant for analysis.
Measured: First Visit (Week 0), Follow Up Visits (Week 52, 104, 156, 208 and 260)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start20 Mar 2026
- Primary completionNov 2033 (estimated)
- Study completionNov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clonal HematopoiesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Clinical Hub for Interventional Research (CHOIR)
- Sponsor type
- Other government
- Collaborators
- Medical Research Future Fund, Australian National University, University of Auckland, New Zealand, The Canberra Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313059
- Sponsor's protocol ID
- 24-CH-001
- Acronym
- CHAPTER
- Status last verified
- May 2026
- First submitted
- 26 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of Incidence, Outcomes and Individuals Experiences Following Diagnosis of Clonal Haematopoiesis in a Dedicated Research Clinic
- ClinicalTrials.gov ID
- NCT07313059
- Acronym / sponsor ID
- CHAPTER / 24-CH-001
- Conditions
- Clonal Hematopoiesis, CCUS Clonal Cytopenia of Undetermined Significance, Hematologic Disease and Disorders
- Keywords
- Clonal Hematopoiesis, CH, CCUS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinical Hub for Interventional Research (CHOIR)Other government
- Collaborators
- Medical Research Future Fund, Australian National University, University of Auckland, New Zealand, The Canberra Hospital
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- Nov 2033 (estimated)
- Study completion
- Nov 2033 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clonal Haematopoiesis (CH) refers to the clonal outgrowth of a population of hematopoietic stem cells in the absence of haematologic neoplasms. The clonal cells share an acquired 'driver' mutation., and the presence of dysplasia and/or cytopenia.
CH is common in older populations, with a frequency of 10-30% in people above 70 years of age.
Most individuals with CH are asymptomatic; however, the condition increases the risk of multiple life-limiting complications, including myeloid neoplasms (MN), cardiovascular disease (CVD), cerebrovascular disease (CeVD) by 11.1, 1.4, and 2-fold, respectively. While CH is not yet treatable, identifying the condition may assist individuals in making informed decisions, including an individualised management plan for early detection of CH-associated complications. CH screening is not currently performed in routine clinical practice.
The optimal approach to surveillance for myeloid neoplasms in individuals with CH remains undefined. Some individuals undergo active surveillance with regular blood count monitoring to detect early progression to MN. Early detection of MN may also broaden the therapeutic window for individuals. Additionally, this allows individuals to connect with suitable clinical trials.
CVD is the most common CH-associated complication; hence CV (cardiovascular) risk modification is important both from an individual and public health standpoint.
CH screening may also refine the evaluation of individuals with unexplained cytopenia, as they may have underlying CH that has not been identified.
Given the uncertainties surrounding the identification and management, dedicated research clinics have been developed in the United States to evaluate the impact of screening of CH. These clinics provide a supportive environment to discuss the condition and engage multidisciplinary management. In addition to haematologists, individuals are supported by other specialities and allied health professionals. However, dedicated CH clinics are not yet available in Australia.
There is an urgent need for more research into CH as there are crucial knowledge gaps. This includes the role of CH screening and interventions to modify the biology and risks of CH-associated complications. Given the widespread use of next-generation sequencing (NGS) panels in Australia, it is likely that CH will be increasingly identified in routine clinical practice, creating a pool of individuals who may benefit from counselling and follow-up in a dedicated service.
This cohort study will establish a screening clinic and a prospectively characterised registry of individuals with CH to serve as the basis for clinical and translational studies in CH.
With consent, individuals with possible CH will undergo screening by molecular testing in the first dedicated multidisciplinary CH clinic in Australia whereby the health outcomes of participants with CH can be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Aged 55 years and above
- Confirmed CH or possible CH, with possible CH defined by:
- Provision of written informed consent prior to any study-related assessments or procedures being carried out.
Key exclusion criteria (8 listed)
- Severe cytopenia as defined by one or more of the following:
- Multilineage cytopenias:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishment of CH participant registry and characterisation of CH outcomes
Time frame: Through study completion, 5 years
7 secondary outcomes
Number and proportion of participants with CH in a population at risk
Time frame: Through study completion, 5 years
Incidence of CH-associated complications
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Screening, Second Visit (Week 6), Follow Up Visits (Week 52, 104, 156, 208, and 260)
Change in VAF in individuals with CH at different timepoints
Time frame: Screening, Follow Up Visits (Week 52, 104, 156, 208 and 260)
Morphological changes by morphological feature analysis of CH changes
Time frame: First Visit (Week 0), Follow Up Visits (Week 52, 104, 156, 208 and 260)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Yen Ng Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clonal Hematopoiesis and CCUS Clonal Cytopenia of Undetermined Significance, run by Clinical Hub for Interventional Research (CHOIR) at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Polizzotto Professor (+61000000000, mosaic.jcsmr@anu.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of CH participant registry and characterisation of CH outcomes (time frame: Through study completion, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.