Polycythemia VeraNCT00666289
Familial Myeloproliferative Disorders
An observational study of Polycythemia Vera and Essential Thrombocythemia, run by Icahn School of Medicine at Mount Sinai at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Polycythemia Vera, Essential Thrombocythemia, Idiopathic Myelofibrosis
- How many people
- 17 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2008to 20 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: families with multiple member diagnosed with myeloproliferative disease
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
Mount Sinai School of Medicine
New York, New York, 10029
Weill Cornell
New York, New York, 10065
University of Utah
Salt Lake City, Utah, 84102
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Molecular Biology of Familial Myeloproliferative Disorders
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.
- Keywords
- polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, family clusters
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine a linkage from the DNA analyzed to find a gene that will allow for genetic evaluation of families with MPDs.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMar 2008
- Primary completion20 Jan 2015
- Study completion20 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Other
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Myeloproliferative Disorders-Research Consortium, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Josef Prachal, MD, Study chair, Myeloproliferative Disorders-Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666289
- Sponsor's protocol ID
- GCO 07-0548-00105
- Other IDs
- P01CA108671-01A2, MPD-RC 105
- Status last verified
- Sep 2017
- First submitted
- 22 Apr 2008
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Biology of Familial Myeloproliferative Disorders
- ClinicalTrials.gov ID
- NCT00666289
- Acronym / sponsor ID
- GCO 07-0548-00105
- Keywords
- polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, family clusters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Myeloproliferative Disorders-Research Consortium, National Cancer Institute (NCI)
- Study start
- Mar 2008
- Primary completion
- 20 Jan 2015 (actual)
- Study completion
- 20 Jun 2015 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Other
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- families with multiple member diagnosed with myeloproliferative disease
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine a linkage from the DNA analyzed to find a gene that will allow for genetic evaluation of families with MPDs.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Prachal, MD study chair
Myeloproliferative Disorders-Research Consortium
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia Vera and Essential Thrombocythemia, run by Icahn School of Medicine at Mount Sinai at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine a linkage from the DNA analyzed to find a gene that will allow for genetic evaluation of families with MPDs. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.