Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients (AML)

Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients

The objective of this study is to evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry. A special emphasis will be focused on monitoring expression of CD200 as well as PGP-170 (MDR1) on blasts cells.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Biological: Blood and Marrow sample

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

• Study Contact: Name: Régis Costello, PU-PH; Phone Number: 04.91.38.41.50; Email: regis.costello@free.fr

Study Locations

• France
  • Marseille, France, 13387
    • Assistance Publique - Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia

Description

Inclusion Criteria:

• Age > 18
• No pregnant woman
• Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia
• Presence of a monitored serum blastose
• Patient who can obtain free and informed consent (speaks French, no guardianship or curatorship)

Exclusion Criteria:

• Minor Patient (< 18 years old)
• Medical or psychological Condition that could interact with the ability to understand the study,
• Pregnant or lactating women,
• Major persons under guardianship or under the protection of justice
• Persons deprived of their liberty by a judicial or administrative decision
• Lack of information and opposition to its participation in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry.	9 mounths

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): March 25, 2022

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2018-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No