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OpenTrials
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NCT Number: NCT00666549

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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Key information

Conditions

Myelofibrosis Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Bone Marrow Neoplasms Essential Thrombocythemia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Idiopathic Myelofibrosis Myeloproliferative Disorders Neoplasms Neoplasms by Site Polycythemia Vera Primary Myelofibrosis Thrombocythemia, Essential Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedali Riuniti di Bergamo, Bergamo, IL, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Myeloproliferative Disorders-Research Consortium
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2008
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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