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

NCT03801005 | Completed

• 1 other identifier: 2018-43
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Blood and Marrow sample BIOLOGICAL

Twenty patients will be included in a prospective way over a period of nine months. No additional medullary or serum samples will be carried out in addition to those required for the clinical routine. Only an additional blood sample taken during a routine blood test will be recovered as part of the research. Just as some leftover bone marrow, taken as part of a usual unused follow-up will be recovered as part of this trial. The persons concerned will be recruited on the occasion of their hospitalisation in one of the hematology services participating in the research, or during their consultation with one of the hematologists of the corresponding service (or services). On this occasion, detailed information on their pathology and research will be given, as well as the information document on the proposed research protocol.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique - Hopitaux de Marseille

Marseille, 13387, France

Location

MeSH Terms

Conditions

Leukemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: January 9, 2019
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

FR (1)