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Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015 (HEMATO-BIO)

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ClinicalTrials.gov Identifier: NCT02320656
Recruitment Status : Recruiting
First Posted : December 19, 2014
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Tracking Information
First Submitted Date  ICMJE December 5, 2014
First Posted Date  ICMJE December 19, 2014
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE May 2014
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping) [ Time Frame: up to 8 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival) [ Time Frame: up to 8 years ]
  • Compare cancer and non-tumor cells genome [ Time Frame: up to 8 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
Official Title  ICMJE Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
Brief Summary

HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.

HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:

  • tumor samples: marrow aspiration, blood sampling.
  • non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Acute Leukemia
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders
Intervention  ICMJE
  • Other: Blood sampling
    Longitudinal (3 stages of the disease)
  • Other: Bone marrow aspirate
    Longitudinal (3 stages of the disease)
  • Other: Skin biopsy
    Single biopsy (optional)
  • Other: Buccal swab
    Single sampling.
Study Arms  ICMJE Experimental: Acute leukemia/myelodysplastic or myeloproliferative disease
Interventions:
  • Other: Blood sampling
  • Other: Bone marrow aspirate
  • Other: Skin biopsy
  • Other: Buccal swab
Publications * Chretien AS, Devillier R, Granjeaud S, Cordier C, Demerle C, Salem N, Wlosik J, Orlanducci F, Gorvel L, Fattori S, Hospital MA, Pakradouni J, Gregori E, Paul M, Rochigneux P, Pagliardini T, Morey M, Fauriat C, Dulphy N, Toubert A, Luche H, Malissen M, Blaise D, Nunes JA, Vey N, Olive D. High-dimensional mass cytometry analysis of NK cell alterations in AML identifies a subgroup with adverse clinical outcome. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2020459118. doi: 10.1073/pnas.2020459118.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
650
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2014)
300
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • acute leukemia, myelodysplastic syndrome or myeloproliferative disease
  • age > 18
  • affiliated to the French Social Security Systm
  • signed informed consent

Exclusion Criteria:

  • emergency
  • patients deprived of liberty or placed under the authority of a tutor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominique Genre, MD +33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane Pakradouni, PharmD,PhD +33491223778 drci.up@ipc.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02320656
Other Study ID Numbers  ICMJE HEMATO-BIO-IPC-2013-015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Institut Paoli-Calmettes
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut Paoli-Calmettes
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Norbert Vey, MD,PhD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP