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To determine whether peripheral blood flow cytometry can reduce or replace invasive bone marrow examinations in patients with slow growing lymphomas.
This study will determine whether peripheral blood flow cytometry can reduce or replace invasive bone marrow examinations in patients with slow growing lymphomas.
Patients with certain types of slow growing (indolent) lymphomas, including the most common sub-type, follicular lymphoma, require a bone marrow examination for staging of their lymphoma. This provides prognostic information and can be important for planning treatment. However, despite the use of local anaesthetic, and in some cases sedation, bone marrow examinations can cause pain and discomfort to patients. Complications are rare but include risk of bleeding, infection and even nerve damage.
Flow cytometry of peripheral blood samples can detect low levels of circulating lymphoma cells. A previous study has demonstrated that detection of lymphoma cells by peripheral blood flow cytometry has a good correlation with bone marrow involvement. This study will seek to find if this correlation is evident in a larger, statistically significant patient cohort. Depending on the study results, invasive and painful bone marrow procedures could potentially be reduced or eliminated in patients with certain slow growing lymphomas. Patients diagnosed with follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma and being treated at the Royal Marsden NHS Foundation Trust will be eligible for this study. Participation in the study will require one peripheral blood sample to be taken before the patient's routine bone marrow biopsy. The study is expected to last between 2 - 3 years for data collection of 108 samples.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Subjects with follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorna Smith | Contact | 020 8915 6187 | lorna.smith2@rmh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Sunil Iyengar | Haematology Consulant, The Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden NHS Foundation Trust | Recruiting | London | Surrey | SW3 6JJ | United Kingdom |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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peripheral blood
| The Royal Marsden NHS Foundation Trust | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |