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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

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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Myelodysplastic Syndromes Myeloproliferative Disorders Other: Blood sampling Other: Bone marrow aspirate Other: Skin biopsy Other: Buccal swab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
Actual Study Start Date : May 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2024


Arm Intervention/treatment
Experimental: Acute leukemia/myelodysplastic or myeloproliferative disease 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.




Primary Outcome Measures :
  1. Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping) [ Time Frame: up to 8 years ]

Secondary Outcome Measures :
  1. Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival) [ Time Frame: up to 8 years ]
  2. Compare cancer and non-tumor cells genome [ Time Frame: up to 8 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02320656


Contacts
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Contact: Dominique Genre, MD +33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane Pakradouni, PharmD,PhD +33491223778 drci.up@ipc.unicancer.fr

Locations
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France
Institut Paoli-Calmettes Recruiting
Marseille, France, 13009
Principal Investigator: Norbert VEY, MD,PhD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Norbert Vey, MD,PhD Institut Paoli-Calmettes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02320656    
Other Study ID Numbers: HEMATO-BIO-IPC-2013-015
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Syndrome
Acute Disease
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease Attributes