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

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ClinicalTrials.gov Identifier: NCT03801005
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment
Leukemia Biological: Blood and Marrow sample

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : January 9, 2021
Estimated Study Completion Date : January 9, 2021

Intervention Details:
  • Biological: Blood and Marrow sample

    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.



Primary Outcome Measures :
  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. [ Time Frame: 9 mounths ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801005


Contacts
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Contact: Régis Costello, PU-PH 04.91.38.41.50 regis.costello@free.fr

Locations
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France
Assistance Publique - Hopitaux de Marseille Recruiting
Marseille, France, 13387
Contact: Regis Costello       regis.costello@ap-hm.fr   
Principal Investigator: Regis Costello         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03801005     History of Changes
Other Study ID Numbers: 2018-43
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No