Research Tissue Bank

Myelofibrosis Clinical Trial

Official title:

Research Tissue Bank

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666549
• Other study ID #: GCO 07-0548-00106
• Secondary ID: P01CA108671-01A2
• Status: Completed
• Start date: September 2007
• Est. completion date: March 27, 2017

Study information

• Verified date: July 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 963
• Est. completion date: March 27, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Idiopathic Myelofibrosis
• Myelofibrosis
• Polycythemia
• Polycythemia Vera
• Primary Myelofibrosis
• Thrombocythemia, Essential
• Thrombocytosis

Locations

Country	Name	City	State
Italy	Ospedali Riuniti di Bergamo	Bergamo	IL
Italy	University of Florence	Florence	IL
United States	Johns Hopkins	Baltimore	Maryland
United States	Roswell Park	Buffalo	New York
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Mount Sinai Medical Center	New York	New York
United States	Palo Alto Medical Foundation Research Institute	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	University of Georgetown	Washington	District of Columbia
United States	Weill Cornell University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Myeloproliferative Disorders-Research Consortium, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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