Research Tissue Bank

Completed

• Conditions: Idiopathic Myelofibrosis; Myelofibrosis; Essential Thrombocythemia; Polycythemia Vera

• Registration Number: NCT00666549
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Primary Completion: 2017-03-27
• Study Completion: 2017-03-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 963

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	3 years

Trial Locations

Locations (11)

Palo Alto Medical Foundation Research Institute; 🇺🇸 Palo Alto, California, United States

Weill Cornell University; 🇺🇸 Washington, District of Columbia, United States

University of Florence; 🇮🇹 Florence, IL, Italy

University of Georgetown; 🇺🇸 Washington, District of Columbia, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, IL, Italy

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Roswell Park; 🇺🇸 Buffalo, New York, United States