NCT00666289

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
2 countries

6 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

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2015

Completed
Last Updated

September 5, 2017

Status Verified

September 1, 2017

Enrollment Period

6.9 years

First QC Date

April 22, 2008

Last Update Submit

September 1, 2017

Conditions

Keywords

polycythemia veraessential thrombocythemiaidiopathic myelofibrosisfamily clusters

Outcome Measures

Primary Outcomes (1)

  • To determine a linkage from the DNA analyzed to find a gene that will allow for genetic evaluation of families with MPDs.

    3 years

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

families with multiple member diagnosed with myeloproliferative disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Weill Cornell

New York, New York, 10065, United States

Location

University of Utah

Salt Lake City, Utah, 84102, United States

Location

University of Florence

Florence, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from subjects and family members with myeloproliferative disease.

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, EssentialPrimary Myelofibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Josef Prachal, MD

    Myeloproliferative Disorders-Research Consortium

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

March 1, 2008

Primary Completion

January 20, 2015

Study Completion

June 20, 2015

Last Updated

September 5, 2017

Record last verified: 2017-09

Locations