Follicular Lymphoma (FL) Clinical Trial
— BMPBOfficial title:
Evaluation of Peripheral Blood (PB) Immunophenotyping in the Detection of Bone Marrow Involvement in Cases of Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL).
To determine whether peripheral blood flow cytometry can reduce or replace invasive bone marrow examinations in patients with slow growing lymphomas.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Individuals =18yrs of age - Able to provide informed written consent - Patients with a diagnosis of follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma requiring staging or re-staging as part of clinical management - pre-transplant bone marrow assessment - High grade transformation associated with the above lymphomas will be allowed. Exclusion Criteria: - Patients with a histological diagnosis other than those mentioned above or those diagnosed with 2 or more different lymphomas, excluding transformed lymphoma. - Patients not fit enough to undergo bone marrow examination. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden NHS Foundation Trust | London | Surrey |
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 | Positive predictive value of PB flow cytometry compared to BM | The primary outcome measure for this study is the positive predictive value of peripheral blood flow cytometry when compared with bone marrow biopsy in determining bone marrow involvement in patients with FL, MCL and MZL. | 3 years | |
Secondary | Negative predictive value of PB flow cytometry compared to BM | The secondary outcome measures for this study are negative predictive value, sensitivity and specificity of peripheral blood flow cytometry when compared with bone marrow biopsy in determining bone marrow involvement in patients with FL, MCL and MZL. | 3 years |
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