Oxford Pre-cancerous Lymphoproliferative Disorders Study (OxPLoreD)
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|ClinicalTrials.gov Identifier: NCT04023747|
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : February 21, 2020
|Condition or disease|
|Pre-cancerous Lymphoproliferative Disorders|
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|
|Estimated Enrollment :||1650 participants|
|Official Title:||Oxford Pre-cancerous Lymphoproliferative Disorders: Analysis and Interception Study|
|Actual Study Start Date :||July 3, 2019|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2026|
Participants with Monoclonal B-Cell Lymphocytosis or Asymptomatic Chronic Lymphocytic Leukaemia
Participants with IgM Monoclonal Gammopathy or Asymptomatic Waldenstrom's Macroglobulinaemia
Participants with IgA or IgG Monoclonal Gammopathy or Smouldering Myeloma
- The identification of predictive markers of progression to malignant disease [ Time Frame: Duration of the study (5 years) ]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.
- Patient reported outcome measures (PROM) via approved quality of life questionnaires. [ Time Frame: Duration of study (5 years) ]Analysis of approved questionnaires: EORTC CLL17
- To study other clinically significant events, not inevitably due to disease progression in this patient cohort [ Time Frame: Duration of study (5 years) ]Assessed by analysing suspected unexpected serious adverse reactions (SUSARs) reported
- Production of evidence-based standard of care guidelines for the monitoring and follow-up of patients with these pre-cancerous conditions [ Time Frame: Duration of study (5 years) ]The identification of relevant markers can be used to create guidelines for optimal monitoring of patients with these pre-cancerous conditions
- Patient reported outcome measures (PROM) via approved quality of life questionnaires. [ Time Frame: Duration of study (5 years) ]Analysis of approved questionnaires: EORTC NHL-LG20
- Patient reported outcome measures (PROM) via approved quality of life questionnaires. [ Time Frame: Duration of study (5 years) ]Analysis of approved questionnaires: EORTC QLQ-C30
- Patient reported outcome measures (PROM) via approved quality of life questionnaires. [ Time Frame: Duration of study (5 years) ]Analysis of approved questionnaires: EORTC QLQ-MY20
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023747
|Contact: Steven Davis||01865 firstname.lastname@example.org|
|Churchill Hospital, Oxford University Hospitals Trust||Recruiting|
|Oxford, United Kingdom, OX3 7LE|
|Contact: Anna Schuh|
|Principal Investigator:||Anna Schuh||University of Oxford|