Familial Myeloproliferative Disorders - Full Text View

Sponsored by:	Myeloproliferative Disorders-Research Consortium
Information provided by:	Myeloproliferative Disorders-Research Consortium
ClinicalTrials.gov Identifier:	NCT00666289

Purpose

Myeloproliferative disorders occur in families, thus giving rise to the theory that it is a genetic disease that may be caused by an abnormal gene in the DNA that can be passed from one generation of family members to another. DNA can be gathered from family members through blood samples and the investigators will investigate (through DNA testing) to see if there are abnormal genes that may be responsible for causing the MPDs. Understanding which genes are responsible for causing MPDs can help develop ways to identify people who may be at risk for developing an MPD, allow for the development of better treatments, possibly a cure, or even prevent the development of MPDs.

Condition
Polycythemia Vera Essential Thrombocythemia Idiopathic Myelofibrosis

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Spleen Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Family-Based
Official Title:	Molecular Biology of Familial Myeloproliferative Disorders

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

Primary Outcome Measures:

To determine a linkage from the DNA analyzed to find a gene that will allow for genetic evaluation of families with MPDs. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood samples from subjects and family members with myeloproliferative disease.

Estimated Enrollment:	200
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	7 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

families with multiple member diagnosed with myeloproliferative disease

Criteria

Inclusion Criteria:

Subjects with polycythemia vera, essential thrombocythemia or idiopathic myelofibrosis who meet the diagnostic criteria established by the World Health Organization.
Family members of subjects suspected of having polycythemia vera, essential thrombocythemia or idiopathic myelofibrosis.
Subject or family members must be 7 years of age or older
A written assent, parental permission or consent must be obtained prior to any study procedures being performed.

Exclusion Criteria:

Subjects who have a known acquired cause of polycythemia (increased hemoglobin/hematocrit), such as people living in high altitudes (in excess of 14,000 feet), subjects with heart disease, left to right heart shunt, severe hypoxia, cyanotic congenital heart disease, or severe pulmonary disease, will be excluded from this study, secondary forms of thrombocytosis and secondary forms of myelofibrosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666289

Contacts

Contact: Josef Prachal, MD	(801) 585-3229	Josef.prchal@hsc.utah.edu
Contact: Neeraj Agarwal, MD	(801) 585-3229

Locations

United States, District of Columbia
Georgetown University	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, New York
Mount Sinai School of Medicine	Recruiting
New York, New York, United States, 10029
Principal Investigator: Ronald Hoffman, MD
United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84102
Principal Investigator: Josef Prachal, MD
Italy
University of Florence	Recruiting
Florence, Italy
Principal Investigator: Alessandro Vannucchi, MD

Sponsors and Collaborators

Myeloproliferative Disorders-Research Consortium

Investigators

Study Chair:

Josef Prachal, MD

Myeloproliferative Disorders-Research Consortium

More Information

Responsible Party:	Myeloproliferative Disorders - Research Consortium ( Josef Prachal, MD - Study Chair )
Study ID Numbers:	MPD-RC 105, P01 Ca 108671-01A2
Study First Received:	April 22, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00666289
Health Authority:	United States: Institutional Review Board

Keywords provided by Myeloproliferative Disorders-Research Consortium:

polycythemia vera
essential thrombocythemia
idiopathic myelofibrosis
family clusters

Study placed in the following topic categories:

Essential thrombocytosis
Polycythemia
Polycythemia Vera
Myelofibrosis
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Myeloproliferative Disorders
Polycythemia vera
Hemostatic Disorders

Myeloid Metaplasia
Thrombocytopathy
Myelofibrosis-osteosclerosis
Lymphatic Diseases
Hemorrhagic Disorders
Hemorrhagic thrombocythemia
Metaplasia
Thrombocytosis
Thrombocythemia, Hemorrhagic
Bone Marrow Diseases

Additional relevant MeSH terms:

Splenic Diseases

ClinicalTrials.gov processed this record on January 16, 2009