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Molecular Biology of Polycythemia and Thrombocytosis

This study is currently recruiting participants.
Verified October 2016 by University of Utah
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722527
First Posted: July 25, 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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Utah
  Purpose
Our study is designed to characterize the clinical picture and genetic pattern of Polycythemia and Thrombocytosis. The purpose of this project is to find a gene and its mutation that causes these disorders. When this is accomplished, new therapies to control and eventually cure the disorder can be designed.

Condition
Polycythemia Thrombocytosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Biology of Polycythemia and Thrombocytosis

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Identify the molecular defect of Polycythemic and Thrombocythemic disorders [ Time Frame: Weekly ]

Biospecimen Retention:   Samples With DNA
Whole blood

Estimated Enrollment: 200
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
Subjects with an elevated hemoglobin concentration or an elevated platelet count

Detailed Description:

Our hypothesis is that genes and their mutation are causative of certain types of polycythemia and thrombocytosis. These will be sought for by genetic and cell biology means. The purpose of the study is to identify the molecular defect of these disorders.

5-7 teaspoons of peripheral blood will be drawn on all study subjects. After DNA is obtained, linkage analysis and/or mutation analysis will be performed.

  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:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have polycythemia and thrombocytosis will be included in the study.
Criteria

Inclusion Criteria:

  1. Subjects with an elevated hemoglobin concentration (>18 in males and >16 in females)
  2. Subjects with an elevated platelet count (>450,000)

Exclusion Criteria:

  1. Subjects who have a known acquired cause of polycythemia and thrombocytosis
  2. Subjects with heart disease, left to right heart shunt or severe pulmonary disease
  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): NCT00722527


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   
Principal Investigator: Josef T Prchal, MD         
Sub-Investigator: Neeraj Agarwal, MD         
Sub-Investigator: Dong Yoon, PhD         
Sub-Investigator: Tatum Simonson, PhD         
Sponsors and Collaborators
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Josef T. Prchal, MD University of Utah
  More Information

Publications:
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00722527     History of Changes
Other Study ID Numbers: 17665
5R01HL050077-13 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2008
First Posted: July 25, 2008
Last Update Posted: October 6, 2016
Last Verified: October 2016

Keywords provided by University of Utah:
Primary Familial and Congenital Polycythemia
Polycythemia
Molecular Biology
Genetics
Erythropoiesis
EPOR mutation
Thrombocytosis
Hypoxia

Additional relevant MeSH terms:
Polycythemia
Thrombocytosis
Hematologic Diseases
Blood Platelet Disorders
Myeloproliferative Disorders
Bone Marrow Diseases