- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621241
Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes (MODIFY)
May 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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
Conditions
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
- Name: Loïc Garçon, PD
- Phone Number: 33 3 22 08 70 56
- Email: garcon.loic@chu-amiens.fr
Study Contact Backup
- Name: Annabelle Boussault
- Email: boussault.annabelle@chu-amiens.fr
Study Locations
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-
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Amiens, France, 80054
- Recruiting
- CHU Amiens-Picardie
-
Contact:
- Loïc Garcon
- Phone Number: 03 22 08 70 56
- Email: garcon.loic@chu-amiens.fr
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Lille, France, 59000
- Not yet recruiting
- CHRU Lille
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Contact:
- Thomas Boyer, MD
- Phone Number: 33 320444783
- Email: THOMAS.BOYER@CHRU-LILLE.FR
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Rouen, France, 76031
- Not yet recruiting
- CHU Rouen
-
Contact:
- Bernard Lenormand
- Phone Number: 333 2 32 88 13 20
- Email: bernard.lenormand@chu-rouen.fr
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-
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:
- Patient who have been orally informed, and given a short written information notice about the study
- Adult patient>18 years
- For whom a blood sample analysis is routinely prescribed
- 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).
- 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2018_843_0010
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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