B-cell Chronic Lymphoid Malignancies Markers (MALYZOMA-II)

July 2, 2021 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Hematology Laboratory - Strasbourg University Hospitals
        • Contact:
        • Principal Investigator:
          • Laurent MAUVIEUX, MD, PhD
        • Sub-Investigator:
          • Laurent MIGUET, MD
        • Sub-Investigator:
          • Caroline MAYEUR-ROUSSE, MD
        • Sub-Investigator:
          • Thibaut FABACHER, MD
        • Sub-Investigator:
          • Ravzan BIZOI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retrospective study of laboratory data from patients with B lymphoid hemopathy, mainly lymphoma in the marginal zone
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Laurent MAUVIEUX, MD, PhD, Hematology Laboratory - Strasbourg University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Anticipated)

January 30, 2023

Study Completion (Anticipated)

March 30, 2023

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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