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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

Tracking Information
First Submitted Date January 9, 2019
First Posted Date January 11, 2019
Last Update Posted Date February 11, 2019
Actual Study Start Date January 9, 2019
Estimated Primary Completion Date January 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2019)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03801005 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients (AML)
Official Title Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia
Condition Leukemia
Intervention 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.

Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 9, 2019)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 9, 2021
Estimated Primary Completion Date January 9, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Régis Costello, PU-PH 04.91.38.41.50 regis.costello@free.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03801005
Other Study ID Numbers 2018-43
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators Not Provided
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date January 2019