We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Polycythemia Vera, Myelofibrosis and Essential Thrombocythemia: Identification of PV, MF & ET Genes

This study is currently recruiting participants.
Verified October 2016 by University of Utah
Sponsor:
ClinicalTrials.gov Identifier:
NCT00715247
First Posted: July 15, 2008
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Utah
  Purpose
The purpose of this project is to find genes whose mutations cause Polycythemia Vera, Essential Thrombocythemia and Primary Myelofibrosis.

Condition
Polycythemia Vera Essential Thrombocythemia Myelofibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Polycythemia Vera, Myelofibrosis and Essential Thrombocythemia: Identification of PV, MF & ET Genes

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Identify genes whose mutations cause Polycythemia Vera, Essential Thrombocythemia and Primary Myelofibrosis. [ Time Frame: Weekly ]

Secondary Outcome Measures:
  • To determine if there are proteins expressed by cells from patients that might be targets for the immune response. [ Time Frame: Weekly ]

Biospecimen Retention:   Samples With DNA
Whole blood and bone marrow aspirate

Estimated Enrollment: 700
Study Start Date: July 2006
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Affected Population
Patients suspected to have one of the following blood disorders: polycythemia vera, myelofibrosis or essential thrombocythemia.
Healthy Female Controls
Healthy females who do not have the blood disorders; Polycythemia Vera, Essential Thrombocythemia and/or 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 acquired. The purpose of this project is to find genes whose mutations cause these disorders, as well as improve diagnostic measures for these diseases. When this is accomplished new therapies to control and eventually cure the disease can be designed.

All subjects will be asked to donate 4-6 teaspoons of blood. On occasion, if the blood cells from a particular sample do not grow well and the DNA from that sample is used up or other tests are needed, we may ask to collect additional samples. In patients who have undergone a bone marrow biopsy as part of their clinical evaluation, we will test the reproducibility between pathologists for the revised 2008 WHO diagnostic criteria to diagnose myeloproliferative disorders (MPD).

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients suspected to have one of the following blood disorders: polycythemia vera, myelofibrosis or essential thrombocythemia.
Criteria

Inclusion Criteria:

  1. Patients with an elevated hemoglobin concentration (>18 in males and >16 in females) and who are suspected to have congenital or acquired primary polycythemia
  2. Patients with a persistent thrombocytosis (>400,000) that does not have an obvious secondary cause
  3. Patients with a bone marrow biopsy that shows increased cellularity and fibrosis
  4. Patients where there is clinical concern for primary myelofibrosis, such as anemia in combination with leukocytosis, thrombocytosis, splenomegaly and/or a leukoerythroblastic blood smear
  5. 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 Criteria:

  1. 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.
  2. Subjects with a known acquired cause of thrombocytosis.
  3. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715247


Contacts
Contact: Josef T Prchal, MD 801-581-4220 josef.prchal@hsc.utah.edu
Contact: Kim Hickman, BS 801-581-3707 kimberly.hickman@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Josef T Prchal, MD    801-581-4220    josef.prchal@hsc.utah.edu   
Contact: Kim Hickman, BS    801-581-3707    kimberly.hickman@hsc.utah.edu   
Sub-Investigator: Neeraj Agarwal, MD         
Sub-Investigator: Mohamed Salama, MD         
Sub-Investigator: Archana Agarwal, MD         
Sub-Investigator: Todd Kelley, MD         
Sub-Investigator: Maurizio Zangari, MD         
Sub-Investigator: Michael Deininger, MD         
Sub-Investigator: Sabina Swierczek, PhD         
Sponsors and Collaborators
University of Utah
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Investigators
Principal Investigator: Josef T Prchal, MD University of Utah
  More Information

Additional Information:
Publications:

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00715247     History of Changes
Other Study ID Numbers: 17793
1P01CA10867101A2 ( Other Grant/Funding Number: NCI )
First Submitted: July 11, 2008
First Posted: July 15, 2008
Last Update Posted: October 6, 2016
Last Verified: October 2016

Keywords provided by University of Utah:
Myeloproliferative Disorders
Hematological Malignancies
Polycythemia Vera
Essential Thrombocythemia
Myelofibrosis
Genetics
Chronic Leukemia

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