Status:
COMPLETED
Polycythemia Vera, Myelofibrosis and Essential Thrombocythemia: Identification of PV, MF & ET Genes
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Conditions:
Polycythemia Vera
Essential Thrombocythemia
Eligibility:
All Genders
Brief Summary
The purpose of this project is to find genes whose mutations cause Polycythemia Vera, Essential Thrombocythemia and Primary Myelofibrosis.
Detailed Description
Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (PMF), also known as the Philadelphia Chromosome negative myeloproliferative disorders (MPDs), are not congenital, but ...
Eligibility Criteria
Inclusion
- Patients with an elevated hemoglobin concentration (\>18 in males and \>16 in females) and who are suspected to have congenital or acquired primary polycythemia
- Patients with a persistent thrombocytosis (\>400,000) that does not have an obvious secondary cause
- Patients with a bone marrow biopsy that shows increased cellularity and fibrosis
- Patients where there is clinical concern for primary myelofibrosis, such as anemia in combination with leukocytosis, thrombocytosis, splenomegaly and/or a leukoerythroblastic blood smear
- Patients with thrombosis at unusual sites, such as Budd-Chiari syndrome, can have early PV before hemoglobin is elevated, these patients will also be included.
Exclusion
- 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 or severe pulmonary disease will be excluded from this study.
- Subjects with a known acquired cause of thrombocytosis.
- Subjects will be excluded if they cannot demonstrate decision making capacity sufficient to agree or decline the blood drawing or use of their blood for the study.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
726 Patients enrolled
Trial Details
Trial ID
NCT00715247
Start Date
July 1 2006
End Date
December 1 2018
Last Update
October 15 2019
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84132