Prospective Clinical Evaluation of Incidence, Outcomes and Individuals Experiences Following Diagnosis of Clonal Haematopoiesis in a Dedicated Research Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Establishment of CH participant registry and characterisation of CH outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 (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.
排除标准
- •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
结局指标
主要结局
Establishment of CH participant registry and characterisation of CH outcomes
时间窗: Through study completion, 5 years
次要结局
- 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 experiencing psychological distress(Screening, Second Visit (Week 6), Follow Up Visits (Week 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))
- Change in VAF in individuals with CH at different timepoints(Screening, Follow Up Visits (Week 52, 104, 156, 208 and 260))
- Morphological changes by morphological feature analysis of CH changes(First Visit (Week 0), Follow Up Visits (Week 52, 104, 156, 208 and 260))