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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 963

Contacts and Locations

Study Locations

• Italy
  • IL
    • Bergamo, IL, Italy
      • Ospedali Riuniti di Bergamo
    • Florence, IL, Italy, 60302
      • University of Florence
• United States
  • California
    • Palo Alto, California, United States, 94301
      • Palo Alto Medical Foundation Research Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 10065
      • Weill Cornell University
    • Washington, District of Columbia, United States, 20057
      • University of Georgetown
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Cancer Institute (NCI); Myeloproliferative Disorders-Research Consortium
• Investigators: Principal Investigator: Lewis Silverman, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): March 27, 2017
• Study Completion (Actual): March 27, 2017

Study Registration Dates

• First Submitted: April 23, 2008
• First Submitted That Met QC Criteria: April 24, 2008
• First Posted (Estimate): April 25, 2008

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Essential Thrombocythemia; Myelofibrosis; Polycythemia Vera; Myeloproliferative Disease; Idiopathic Myelofibrosis
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Blood Coagulation Disorders; Blood Platelet Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Primary Myelofibrosis; Thrombocytosis; Thrombocythemia, Essential; Polycythemia Vera; Polycythemia
• Other Study ID Numbers: GCO 07-0548-00106; P01CA108671-01A2 (U.S. NIH Grant/Contract); MPD-RC 106 (Other Identifier: Myeloproliferative Disorders-Research Consortium)