Natural Killer Cells and Polycythemia Vera (Vaquez's Disease)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284712
First received: August 3, 2009
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

Natural Killer cells (NK) are pivotal cells of innate immunity, that sense defective expression of HLA class I molecules and are complementary to specific cytotoxic T lymphocytes. A defect in NK cell cytotoxicity has been described in some hematopoietic malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms. This defect is at least partially linked to a decreased or absent expression of some activating NK cell molecules, more particularly the so-called Natural Cytotoxicity Receptors (NCRs) NKp30, NKp44 and NKp46. Some old publications have demonstrated defective NK cytotoxicity in myeloproliferative syndroms (chronic myeloid leukemia, primary thrombocytosis, polycythemia vera). The investigators more particularly focused their attention on polycythemia vera (Vaquez's disease), a myeloproliferative disease characterized by the recently describet mutation V617F of the JAK2 tyrosine kinase. The investigators will precise the mechanisms leading to this cytotoxicity defect, the investigators also will evaluate the implication of V617F mutation on NK physiology, and will study the interactions between NK cells and hematopoietic progenitors.


Condition Intervention
Polycythemia Vera
Biological: blood sample

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To describe immunologic anomalies in polycythemia vera [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: July 2009
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: blood sample
    blood sample coming from therapeutic bleeding in hospital
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

VAQUEZ'S DISEASE

Criteria

Inclusion Criteria:

  • Polycythemia vera
  • Treatment by therapeutic bleedings
  • No cytotoxic treatment during the previous six months

Exclusion Criteria:

  • No Polycythemia vera
  • No treatment by therapeutic bleedings
  • Cytotoxic treatment during the previous six months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284712

Contacts
Contact: Regis Costello 3349168606

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

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01284712     History of Changes
Other Study ID Numbers: 2009/16, 2009-A00395-52
Study First Received: August 3, 2009
Last Updated: August 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
treatment by bleedings

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on August 28, 2014