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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00666549
Other study ID # GCO 07-0548-00106
Secondary ID P01CA108671-01A2
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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