BMPB: Blood Immunophenotyping in Staging of Indolent B-cell Lymphomas V1.0

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT03265158
Collaborator
(none)
108
2
32.4
54
1.7

Study Details

Study Description

Brief Summary

To determine whether peripheral blood flow cytometry can reduce or replace invasive bone marrow examinations in patients with slow growing lymphomas.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    108 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official 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).
    Actual Study Start Date :
    Jul 19, 2017
    Anticipated Primary Completion Date :
    Apr 1, 2020
    Anticipated Study Completion Date :
    Apr 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Positive predictive value of PB flow cytometry compared to BM [3 years]

      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.

    Secondary Outcome Measures

    1. Negative predictive value of PB flow cytometry compared to BM [3 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Royal Marsden NHS Foundation Trust London Surrey United Kingdom SW3 6JJ
    2 The Royal Marsden NHS Foundation Trust Sutton Surrey United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Royal Marsden NHS Foundation Trust

    Investigators

    • Principal Investigator: Sunil Iyengar, Haematology Consulant, The Royal Marsden NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royal Marsden NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT03265158
    Other Study ID Numbers:
    • CCR4595
    First Posted:
    Aug 29, 2017
    Last Update Posted:
    Aug 29, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 29, 2017