OxPLoreD is an observational cohort study to identify clinical, genomic and immunological predictive markers of progression to malignant disease. Open to individuals diagnosed in the last 3 years with high count MBL, Binet Stage A CLL, Immunoglobulin G/A/M (IgG, IgA, IgM) MGUS, asymptomatic WM not requiring treatment and smouldering myeloma not requiring treatment.
The purpose of the study is to monitor patients with early stage lymphoproliferative disorders not meeting criteria for treatment, including early stage Chronic Lymphocytic Leukaemia (CLL), Monoclonal B-cell Lymphocytosis (MBL), Monoclonal Gammopathy of Uncertain Significance (MGUS), asymptomatic Waldenstroms Macroglobulinaemia (WM) and Smouldering Myeloma (SM). Each of these disorders has a pre-cancerous phase when abnormalities can be seen in the blood, however treatment may not be required. A minority of people with early stage lymphoproliferative disorders will go on to need treatment for blood or bone marrow cancer. Currently the investigators do not have a reliable way to predict which of these individuals with these disorders are more likely to develop a blood or bone marrow cancer. By studying a large group of individuals over time we hope to discover more about what factors might predict progression. The investigators may be able to identify markers which identify individuals who are more or less likely to develop blood or bone marrow cancer. These markers might be particular symptoms, gene changes called mutations or levels of particular molecules or cells in the blood or bone marrow. In the longer term this may enable us to identify those people who would benefit from certain types of treatment or from receiving treatment at an earlier stage and also to confidently reassure those who will never progress. Patients will be studied for up to 5 years with blood, bone marrow and saliva samples taken at key time-points to help answer these questions. In addition to looking for these markers we will also collect information about: * What it is like to live with one of these conditions * How many people with these conditions develop other significant medical conditions, such as serious infections, thrombosis (blood clots) or other types of cancer.
Study Type
OBSERVATIONAL
Enrollment
574
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
James Paget Hospital
The identification of predictive markers of progression to malignant disease
Relevant markers will be identified from the analysis of the clinical data in combination with the genomic and immunological data from the samples collected. The markers will be combined to produce a single probability risk score. The choice of relevant markers will be guided by emerging evidence and techniques under the guidance of the study scientific advisory board.
Time frame: Duration of the study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Analysis of approved questionnaires: EORTC CLL17
Time frame: Duration of study (5 years)
To study other clinically significant events, not inevitably due to disease progression in this patient cohort
Assessed by analysing suspected unexpected serious adverse reactions (SUSARs) reported
Time frame: Duration of study (5 years)
Production of evidence-based standard of care guidelines for the monitoring and follow-up of patients with these pre-cancerous conditions
The identification of relevant markers can be used to create guidelines for optimal monitoring of patients with these pre-cancerous conditions
Time frame: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Analysis of approved questionnaires: EORTC NHL-LG20
Time frame: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Analysis of approved questionnaires: EORTC QLQ-C30
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Great Yarmouth, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Clatterbridge Cancer Centre
Liverpool, United Kingdom
Epsom Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
Northern Centre for Cancer Care
Newcastle, United Kingdom
North Tyneside General Hospital
North Shields, United Kingdom
...and 7 more locations
Time frame: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Analysis of approved questionnaires: EORTC QLQ-MY20
Time frame: Duration of study (5 years)