Cytopenia Clinical Trial
Official title:
Improving Diagnosis in Idiopathic Cytopenia Using Gene Sequencing
10% of the cases referred to the specialist diagnostic haemato-pathology service at RMH are
for cytopenias.
The hypothesis to be tested is that a proportion of patients with idiopathic cytopenias have
mutations in myelodysplasic syndrome (MDS)-associated genes. The investigators will sequence
a panel of known MDS-associated genes in patient material (bone marrow and blood) that is
sent routinely to the diagnostic service where conventional techniques have failed to
establish a clear diagnosis. 200 patients with idiopathic cytopenia will be followed up to
determine their survival, blood counts and development of acute leukaemia and other
haematological malignancies. The clinical outcomes will be correlated with any mutations
detected.
Status | Recruiting |
Enrollment | 285 |
Est. completion date | April 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Signed informed consent - Patients >= 18 years old - Life expectancy more than 12 months - Cytopenia defined as Hb < 110g/L and/or Neutrophils <1.5 x109/L and/or Platelets <100 x109/L Exclusion Criteria: - Known haematological malignancy or aplastic anaemia/paroxysmal nocturnal haemoglobinuria - Cytopenia of known aetiology (after examination of blood film and other investigations have occurred). These include haematinic deficiency (patients unresponsive to appropriate haematinic deficiency may enter the study), autoimmune cytopenias, chronic renal anaemia (for those with isolated anaemia), known haemoglobinopathy (for those with isolated anaemia), chronic viral diseases (Hep B/C/HIV), cytopenias associated with liver disease, cytopenias associated with systemic autoimmune conditions (eg SLE, rheumatoid arthritis), anaemia of chronic disease (for those with isolated anaemia). - Cytotoxic chemotherapy or other myelosuppressive drugs or radiotherapy within 12 months - Inadequate bone marrow sample for gene testing |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | Surrey |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with idiopathic cytopenia with a mutation | 5 years |
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