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Research Tissue Bank

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Icahn School of Medicine at Mount Sinai
Sponsor:
Collaborators:
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00666549
First received: April 23, 2008
Last updated: August 3, 2016
Last verified: August 2016

April 23, 2008
August 3, 2016
September 2007
June 2019   (final data collection date for primary outcome measure)
To collect and store tissue specimens from patients with MPDs including PV, IM, ET. The samples will be used to conduct laboratory investigations to help define mechanisms involved in the pathophysiology and treatment of these disorders. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00666549 on ClinicalTrials.gov Archive Site
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Research Tissue Bank
Research Tissue Bank

This study that will allow for the preservation and/or storage of a small portion one or more of the following tissues:

  • Peripheral blood
  • Bone marrow
  • Bone marrow biopsy
  • A phlebotomized unit of blood
  • Spleen cells
  • Toenail clippings

This material will be used for the study of Myeloproliferative Disorders (MPD) by researchers. The goals of this research study are to understand the causes of MPDs, how to diagnose them more easily and how to treat them better. MPD is a disease affecting hematopoietic stem cells. Hematopoietic stem cells are cells that make blood cells. These stem cells grow in the center portion of the bones called bone marrow. Under some conditions, these cells are also found in blood. There are several diseases, which are classified as MPD. These include polycythemia vera (too many red blood cells), essential thrombocythemia (too many platelets), and idiopathic myelofibrosis (abnormal blood cells and fibers build up in the bone marrow). These syndromes carry a high risk of developing leukemia. It is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments.

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Observational
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Retention:   Samples With DNA
Description:
Blood, bone marrow, bone marrow biopsy, toenail clippings, phlebotomized blood, spleen cells
Non-Probability Sample
Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible and not currently participating in any MPD-RC treatment studies.
  • Myelofibrosis
  • Idiopathic Myelofibrosis
  • Essential Thrombocythemia
  • Polycythemia Vera
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2019
June 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible.
  • Newly diagnose MPD patients as well as previously treated for a MPD are eligible.
  • Signed informed consent is required from each patient at the time of enrollment.

Exclusion Criteria:

  • Patients currently participating in experimental treatment arms of MPD-RC protocols, or other experimental treatment protocols are not eligible during the period they are on study.
Both
18 Years and older   (Adult, Senior)
No
Contact: Rona S Weinberg, PhD (212) 570-3412 rweinberg@nybloodcenter.org
United States,   Italy
Sweden
 
NCT00666549
GCO 07-0548-00106, P01CA108671-01A2, MPD-RC 106
Yes
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Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
  • Myeloproliferative Disorders-Research Consortium
  • National Cancer Institute (NCI)
Study Chair: Rona S Weinberg, PhD Myeloproliferative Disorders-Research Consortium
Principal Investigator: Lewis Silverman, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
August 2016

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