Familial Myeloproliferative Disorders

Polycythemia Vera Clinical Trial

Official title:

Molecular Biology of Familial Myeloproliferative Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666289
• Other study ID #: GCO 07-0548-00105
• Secondary ID: P01CA108671-01A2
• Status: Completed
• Phase: N/A
• First received: April 22, 2008
• Last updated: September 1, 2017
• Start date: March 2008
• Est. completion date: June 20, 2015

Study information

• Verified date: September 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 20, 2015
• Est. primary completion date: January 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Families with 2 or more members diagnosed with polycythemia vera (PV), essential thrombocythemia (ET), PV and ET related myelofibrosis (PV-MF and ET-MF), idiopathic myelofibrosis (IM) or chronic myelogenous leukemia (CML).

• Healthy family members of subjects diagnosed with a myeloproliferative neoplasm (MPN).

• Participating subjects 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.

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Idiopathic Myelofibrosis
• Myeloproliferative Disorders
• Polycythemia
• Polycythemia Vera
• Primary Myelofibrosis
• Thrombocythemia, Essential
• Thrombocytosis

Locations

Country	Name	City	State
Italy	University of Florence	Florence
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Mount Sinai School of Medicine	New York	New York
United States	Weill Cornell	New York	New York
United States	University of Utah	Salt Lake City	Utah
United States	Georgetown University	Washington, D.C.	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Myeloproliferative Disorders-Research Consortium, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine a linkage from the DNA analyzed to find a gene that will allow for genetic evaluation of families with MPDs.		3 years