MyelofibrosisNCT00666549
Research Tissue Bank
An observational study of Myelofibrosis and Idiopathic Myelofibrosis, run by Icahn School of Medicine at Mount Sinai at 11 sites in 2 countries.
Trial summary
This study that will allow for the preservation and/or storage of a small portion one or more of the following tissues: Peripheral blood Bone marrow Bone marrow biopsy A phlebotomized unit of blood Spleen cells Toenail clippings This material will be used for the study of Myeloproliferative Disorders (MPD) by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Idiopathic Myelofibrosis, Essential Thrombocythemia
- How many people
- 963 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Sep 2007to 27 Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible and not currently participating in any MPD-RC treatment studies.
Who may be able to join
- Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible.
- Newly diagnose MPD patients as well as previously treated for a MPD are eligible.
- Signed informed consent is required from each patient at the time of enrollment.
Who cannot join
- Patients currently participating in experimental treatment arms of MPD-RC protocols, or other experimental treatment protocols are not eligible during the period they are on study.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Johns Hopkins
Baltimore, Maryland, 21205
Roswell Park
Buffalo, New York, 14263
University of Illinois at Chicago
Chicago, Illinois, 60612
Mount Sinai Medical Center
New York, New York, 10029
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
University of Utah
Salt Lake City, Utah, 84102
Weill Cornell University
Washington D.C., District of Columbia, 10065
University of Georgetown
Washington D.C., District of Columbia, 20057
Italy2 sites
Ospedali Riuniti di Bergamo
Bergamo, IL
University of Florence
Florence, IL, 60302
About this study
This study that will allow for the preservation and/or storage of a small portion one or more of the following tissues:
- Peripheral blood
- Bone marrow
- Bone marrow biopsy
- A phlebotomized unit of blood
- Spleen cells
- Toenail clippings
This material will be used for the study of Myeloproliferative Disorders (MPD) by researchers. The goals of this research study are to understand the causes of MPDs, how to diagnose them more easily and how to treat them better. MPD is a disease affecting hematopoietic stem cells. Hematopoietic stem cells are cells that make blood cells. These stem cells grow in the center portion of the bones called bone marrow. Under some conditions, these cells are also found in blood. There are several diseases, which are classified as MPD. These include polycythemia vera (too many red blood cells), essential thrombocythemia (too many platelets), and idiopathic myelofibrosis (abnormal blood cells and fibers build up in the bone marrow). These syndromes carry a high risk of developing leukemia. It is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments.
- Keywords
- Myeloproliferative Disease, Myelofibrosis, Idiopathic Myelofibrosis, Essential Thrombocythemia, Polycythemia Vera
- Medical subject headings
- Primary Myelofibrosis, Thrombocythemia, Essential, Polycythemia Vera, Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect and store tissue specimens from patients with MPDs including PV, IM, ET. The samples will be used to conduct laboratory investigations to help define mechanisms involved in the pathophysiology and treatment of these disorders.
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 posted25 Apr 2008 (estimated)
- Study startSep 2007
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 963 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
- Rona S Weinberg, PhD, Study chair, Myeloproliferative Disorders-Research ConsortiumLewis Silverman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666549
- Sponsor's protocol ID
- GCO 07-0548-00106
- Other IDs
- P01CA108671-01A2, MPD-RC 106
- Status last verified
- Jul 2019
- First submitted
- 23 Apr 2008
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Tissue Bank
- ClinicalTrials.gov ID
- NCT00666549
- Acronym / sponsor ID
- GCO 07-0548-00106
- Keywords
- Myeloproliferative Disease, Myelofibrosis, Idiopathic Myelofibrosis, Essential Thrombocythemia, Polycythemia Vera
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 963 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
- Sep 2007
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 25 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.
This study that will allow for the preservation and/or storage of a small portion one or more of the following tissues:
- Peripheral blood
- Bone marrow
- Bone marrow biopsy
- A phlebotomized unit of blood
- Spleen cells
- Toenail clippings
This material will be used for the study of Myeloproliferative Disorders (MPD) by researchers. The goals of this research study are to understand the causes of MPDs, how to diagnose them more easily and how to treat them better. MPD is a disease affecting hematopoietic stem cells. Hematopoietic stem cells are cells that make blood cells. These stem cells grow in the center portion of the bones called bone marrow. Under some conditions, these cells are also found in blood. There are several diseases, which are classified as MPD. These include polycythemia vera (too many red blood cells), essential thrombocythemia (too many platelets), and idiopathic myelofibrosis (abnormal blood cells and fibers build up in the bone marrow). These syndromes carry a high risk of developing leukemia. It is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible and not currently participating in any MPD-RC treatment studies.
Key inclusion criteria (3 listed)
- Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible.
- Newly diagnose MPD patients as well as previously treated for a MPD are eligible.
- Signed informed consent is required from each patient at the time of enrollment.
Key exclusion criteria (1 listed)
- Patients currently participating in experimental treatment arms of MPD-RC protocols, or other experimental treatment protocols are not eligible during the period they are on study.
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 collect and store tissue specimens from patients with MPDs including PV, IM, ET. The samples will be used to conduct laboratory investigations to help define mechanisms involved in the pathophysiology and treatment of these disorders.
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 Jul 2019.
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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.
Rona S Weinberg, PhD study chair
Myeloproliferative Disorders-Research Consortium
Lewis Silverman, MD principal investigator
Icahn School of Medicine at Mount Sinai
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis and Idiopathic Myelofibrosis, run by Icahn School of Medicine at Mount Sinai at 11 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 3 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 collect and store tissue specimens from patients with MPDs including PV, IM, ET. The samples will be used to conduct laboratory investigations to help define mechanisms involved in the pathophysiology and treatment of these disorders. (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 Jul 2019.