NCT00433862

Brief Summary

The three main chronic myeloproliferative disorders are polycythemia vera (PV), essential thrombocythemia (ET) and idiopathic myelofibrosis (IMF). These are clonal neoplastic diseases characterized by proliferation of one or more hematopoietic lineages. Recently a mutation of the Janus Kinase 2 (JAK2) gene that leads to the substitution of phenylalanine for valine at position 617 of the JAK2 protein, JAK2 V617F, has been found in 76% to 97% of patients with PV, 29% to 57% of patients with ET and 50% of patients with IMF. This mutation confers constitutive activity on to the JAK2 protein and appears to play an important role in the pathobiology of these conditions. However, not all patients with myeloproliferative disorders have this mutation and it may not be the primary cause of these diseases. The primary goal of this prospective natural history study is to investigate the molecular basis of these diseases in groups of patients who have JAK2 V617F and in those who do not. A second goal is to identify biomarkers for PV and the other myeloproliferative disorders that are easier to measure than JAK2 V617F. Approximately, 150 patients with myeloproliferative disorders will be studied over 3 years. The studies will involve the collection of 40 mL to 50 mL of peripheral blood from each subject. The blood will be used to assess neutrophil gene and protein expression, gene polymorphisms, and plasma protein levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2010

Completed
Last Updated

July 2, 2017

Status Verified

May 19, 2010

First QC Date

February 9, 2007

Last Update Submit

June 30, 2017

Conditions

Polycythemia VeraEssential ThrombocytosisIdiopathic MyelofibrosisNeutrophilsChronic Myeloproliferative Disorders

Keywords

Polycythemia VeraEssential ThrombocytosisIdiopathic MyelofibrosisJanus Kinase 2CD177Chronic Myeloproliferative DisordersPVEssential ThrombocythemiaETIM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis or suspected diagnosis of PV, ET, or IMF. The World Health Organization Criteria will be used for diagnosing this disorder. In brief, the criteria for PV is hemoglobin greater than 18.5 g/dL in men and greater than 16.5 g/dL in women and splenomegaly on palpation in the absence of secondary erythrocytosis. If splenomegaly is absent, the patient must have 2 of the following 4 minor criteria: platelet count greater than 400 x 10(9)/L, leukocyte count greater than 12 x 10(9)/L, marrow biopsy with trilineage increase in cellularity, and low serum erythropoietin level. The criteria for EF is a platelet count greater than 600 x 10(9)/L with no known cause of reactive thrombocytosis and a normal hemoglobin. The criteria for IMF is fibrosis of the bone marrow and splenomegaly without preceding PV, ET or chronic myelogenous leukemia.
  • Both male and female subjects will be studied.
  • Any ethnic group.
  • years of age or older.

You may not qualify if:

  • Subjects will be excluded if they have any of the following conditions:
  • Increased blood counts due to a disease other than chronic myeloproliferation.
  • Know history of anemia (hematocrit less than 12.0 mg/dL).
  • Pregnancy.
  • Infection with HIV, hepatitis B, or hepatitis C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Medical Center, Washington D.C.

Washington D.C., District of Columbia, 20422, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • DAMESHEK W. Some speculations on the myeloproliferative syndromes. Blood. 1951 Apr;6(4):372-5. No abstract available.

    PMID: 14820991BACKGROUND

  • Spivak JL. Polycythemia vera: myths, mechanisms, and management. Blood. 2002 Dec 15;100(13):4272-90. doi: 10.1182/blood-2001-12-0349. Epub 2002 Aug 8. No abstract available.

    PMID: 12393615BACKGROUND

  • el-Kassar N, Hetet G, Briere J, Grandchamp B. Clonality analysis of hematopoiesis in essential thrombocythemia: advantages of studying T lymphocytes and platelets. Blood. 1997 Jan 1;89(1):128-34.

    PMID: 8978285BACKGROUND

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, EssentialPrimary MyelofibrosisMyeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 12, 2007

Study Start

February 6, 2007

Study Completion

May 19, 2010

Last Updated

July 2, 2017

Record last verified: 2010-05-19

Locations

US(2)