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NCT04952974 Clinical Trial

B-cell Chronic Lymphoid Malignancies Markers

Chronic Lymphocytic Leukemia Clinical Trial

— MALYZOMA-II  

Official title:
Study of Cell Markers of Marginal Zone Lymphoma and Other B-cell Chronic Lymphoid Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04952974
Other study ID # 8205
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 14, 2021
Est. completion date March 30, 2023

Study information
Verified date May 2021
Source University Hospital, Strasbourg, France
Contact Laurent MAUVIEUX, MD, PhD
Phone 33 3 88 12 75 27
Email laurent.mauvieux@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lymphoid chronic B-cell malignancies are frequent pathologies that affect adults, with a very variable prognosis and treatment (some of them can remain untreated). The diagnosis of these malignancies relies on the study of the morphology of tumoral cells and the expression by these cells of several markers, mainly via a technical approach called flow cytometry. Because the markers currently used remain imperfect, additional ones are needed for an accurate diagnosis that affect both prognosis and treatment. In addition, because numerous markers are used at the diagnosis, there is a need of tools that synthetize the multi-dimensional structure of the data obtained. The primary purpose of this study is to detect new markers that can be of help for the diagnosis of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies. The secondary purpose of this study is to obtain a statistical algorithm that allow a good prediction of the different sub-types of chronic B-cell malignancies mainly using the results of flow cytometry.

Recruitment information / eligibility
Status Recruiting
Enrollment 420
Est. completion date March 30, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies - patients that gave their informed consent for the conservation of blood or bone marrow cells (primary objective 1) - patients that gave their informed consent for the retrospective use of their clinical and biological data Exclusion Criteria: - patients under guardianship or curatorship - patients who did not gave their consent for the use of their cells and/or data

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Hematology Laboratory - Strasbourg University Hospitals Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retrospective study of laboratory data from patients with B lymphoid hemopathy, mainly lymphoma in the marginal zone 2 years
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