Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes (MODIFY)

Myelodysplastic syndromes (MDS) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. Morphological analysis of peripheral blood (PB) and bone marrow (BM) remains the cornerstone of the diagnosis. Preliminary studies identified Flow Cytometry (FC) markers on red cells, platelets and circulating leukocytes that are expressed differently in MDS and in controls. However, these markers have been evaluated separately. The investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a PB FC-based diagnosis score that would discriminate between MDS and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

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 Contact Backup

Study Locations

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

Sampling Method

Non-Probability Sample

Study Population

MDS

Description

Inclusion Criteria:

  1. Patient who have been orally informed, and given a short written information notice about the study
  2. Adult patient>18 years
  3. For whom a blood sample analysis is routinely prescribed
  4. Presenting cytopenia on at least one lineage according to the 2016 WHO classification (Hemoglobin level<100 g/L and/or platelets <150 G/L and/or Neutrophils<1G/L).
  5. For whom a bone marrow analysis for morphology assessment and cytogenetics have to be performed, because of suspicion of MDS.t The results of this bone marrow evaluation will classify the patients in Group 1 (MDS diagnosis) and Group 2 (no MDS according to the 2016 WHO criteria), defining the two populations of this validation cohort for whom the FC score will be calculated.

Exclusion Criteria:

1. Transfused patients (less than 3 months) in RBC or platelets units

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
identification of the most relevant combination of FC markers
Time Frame: 0 days
The main objective is to identify the most relevant combination of FC markers to discriminate between already diagnosed MDS patients and non-MDS patients.
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prospective validation of a diagnostic score using pre-identified markers
Time Frame: 0 days
The secondary objective is to build prospectively a diagnostic score using markers identified
0 days

Collaborators and Investigators

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

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 15, 2018

Primary Completion (Anticipated)

August 15, 2023

Study Completion (Anticipated)

May 17, 2024

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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