Clinical trial NCT00666549: Research Tissue Bank
Official title: Research Tissue Bank
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelofibrosis
Idiopathic Myelofibrosis
Essential Thrombocythemia
Polycythemia Vera
Keywords: Myeloproliferative Disease
Myelofibrosis
Idiopathic Myelofibrosis
Essential Thrombocythemia
Polycythemia Vera
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Myeloproliferative Disorders-Research Consortium
name: National Cancer Institute (NCI)
First posted: 2008-04-25
Enrollment: 963
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: Washington
country: United States
facility: Weill Cornell University
state: District of Columbia
city: Washington
country: United States
facility: University of Georgetown
state: District of Columbia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Buffalo
country: United States
facility: Roswell Park
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
state: IL
city: Florence
country: Italy
facility: University of Florence
state: IL
Study officials:
affiliation: Myeloproliferative Disorders-Research Consortium
name: Rona S Weinberg, PhD
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: Lewis Silverman, MD
role: PRINCIPAL_INVESTIGATOR
References: