Research Tissue Bank

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT00666549

Collaborator

Myeloproliferative Disorders-Research Consortium (Other), National Cancer Institute (NCI) (NIH)

963

Enrollment

Locations

114.8

Duration (Months)

87.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelofibrosis Idiopathic Myelofibrosis Essential Thrombocythemia Polycythemia Vera

Study Design

Study Type:

Observational

Actual Enrollment :

963 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Research Tissue Bank

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Mar 27, 2017

Actual Study Completion Date :

Mar 27, 2017

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto Medical Foundation Research Institute	Palo Alto	California	United States	94301
2	Weill Cornell University	Washington	District of Columbia	United States	10065
3	University of Georgetown	Washington	District of Columbia	United States	20057
4	University of Illinois at Chicago	Chicago	Illinois	United States	60612
5	Johns Hopkins	Baltimore	Maryland	United States	21205
6	Roswell Park	Buffalo	New York	United States	14263
7	Mount Sinai Medical Center	New York	New York	United States	10029
8	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19107
9	University of Utah	Salt Lake City	Utah	United States	84102
10	Ospedali Riuniti di Bergamo	Bergamo	IL	Italy
11	University of Florence	Florence	IL	Italy	60302

Sponsors and Collaborators

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

Investigators

Study Chair: Rona S Weinberg, PhD, Myeloproliferative Disorders-Research Consortium
Principal Investigator: Lewis Silverman, MD, Icahn School of Medicine at Mount Sinai