Blood Immunophenotyping in Staging of Indolent B-cell Lymphomas V1.0
BMPB
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).
1 other identifier
observational
108
1 country
2
Brief Summary
To determine whether peripheral blood flow cytometry can reduce or replace invasive bone marrow examinations in patients with slow growing lymphomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 19, 2017
CompletedFirst Submitted
Initial submission to the registry
August 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedAugust 29, 2017
August 1, 2017
2.7 years
August 25, 2017
August 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Negative predictive value of PB flow cytometry compared to BM
3 years
Eligibility Criteria
Subjects with follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Royal Marsden NHS Foundation Trust
London, Surrey, SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
Biospecimen
peripheral blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunil Iyengar
Haematology Consulant, The Royal Marsden NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2017
First Posted
August 29, 2017
Study Start
July 19, 2017
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
August 29, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share