Research Tissue Bank

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Myeloproliferative Disorders-Research Consortium
Sponsor:
Information provided by (Responsible Party):
Myeloproliferative Disorders-Research Consortium
ClinicalTrials.gov Identifier:
NCT00666549
First received: April 23, 2008
Last updated: September 9, 2012
Last verified: September 2012
  Purpose

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
Myelofibrosis
Idiopathic Myelofibrosis
Essential Thrombocythemia
Polycythemia Vera

Study Type: Observational
Official Title: Research Tissue Bank

Resource links provided by NLM:


Further study details as provided by Myeloproliferative Disorders-Research Consortium:

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, bone marrow, bone marrow biopsy, toenail clippings, phlebotomized blood, spleen cells


Estimated Enrollment: 400
Study Start Date: September 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666549

Contacts
Contact: Rona S Weinberg, PhD (212) 570-3412 rweinberg@nybloodcenter.org

Locations
United States, California
Palo Alto Medical Foundation Research Institute Recruiting
Palo Alto, California, United States, 94301
Principal Investigator: David Leibowitz, MD         
United States, District of Columbia
Weill Cornell University Recruiting
Washington, District of Columbia, United States, 10065
Principal Investigator: Tsiporah Shore, MD         
University of Georgetown Recruiting
Washington, District of Columbia, United States, 20057
Principal Investigator: Craig Kessler, MD         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Damiano Rondelli, MD         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Jerry Spivak, MD         
United States, New York
Roswell Park Recruiting
Buffalo, New York, United States, 14263
Principal Investigator: Minocher Battiwalla, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Principal Investigator: Lewis Silverman, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Elizabeth Hexner, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84102
Principal Investigator: Josef Prachal, MD         
Italy
Ospedali Riuniti di Bergamo Recruiting
Bergamo, IL, Italy
Principal Investigator: Alessandro Rambaldi, MD         
University of Florence Recruiting
Florence, IL, Italy, 60302
Principal Investigator: Alessandro Vannucchi, MD         
Sponsors and Collaborators
Myeloproliferative Disorders-Research Consortium
Investigators
Study Chair: Rona S Weinberg, PhD Myeloproliferative Disorders-Research Consortium
  More Information

No publications provided

Responsible Party: Myeloproliferative Disorders-Research Consortium
ClinicalTrials.gov Identifier: NCT00666549     History of Changes
Other Study ID Numbers: MPD-RC 106, P01 Ca 108671-01A2
Study First Received: April 23, 2008
Last Updated: September 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Myeloproliferative Disorders-Research Consortium:
Myeloproliferative Disease
Myelofibrosis
Idiopathic Myelofibrosis
Essential Thrombocythemia
Polycythemia Vera

Additional relevant MeSH terms:
Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocytosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 26, 2014