Correlative Biomarker Study in Patients With Myeloproliferative Disorders
This study is currently recruiting participants.
Verified February 2013 by Mount Sinai School of Medicine
Sponsor:
Mount Sinai School of Medicine
Collaborators:
Myeloproliferative Disorders-Research Consortium
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00665067
First received: April 21, 2008
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
Researchers will use abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma, in laboratory studies. Toenail clippings will provide normal material like DNA for comparison with the abnormal material derived from the blood and/or bone marrow. The results of these studies will be correlated with subjects' disease symptoms and response to their experimental treatment. The MPD-RC researchers are interested in studying molecules from the blood and bone marrow, the exact molecules changing over time with the investigators choosing only the most promising for investigation.
The investigators are attempting to better understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases. 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. It is believed that further basic knowledge about these cancer cells as well as the effects of treatment will lead to the improvement of current therapies and the development of entirely new treatments for these diseases. The MPD-RC is hoping to determine if a number of laboratory tests (biomarkers) will allow for the prediction of response in future patients to the treatment they would receive.
| Condition |
|---|
|
Myeloproliferative Disease Myelofibrosis Idiopathic Myelofibrosis Essential Thrombocythemia Polycythemia Vera |
| Study Type: | Observational |
| Official Title: | Correlative Biomarker Study for MPD-RC Treatment Studies in the Philadelphia Chromosome Negative MPD |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential thrombocythemia
polycythemia vera
primary myelofibrosis
tetrasomy 18p
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by Mount Sinai School of Medicine:
Primary Outcome Measures:
- To collect and store tissue samples from patients with myeloproliferative disorders (PV,IM,and ET). Tissue samples will be used to perform a variety of biomarker studies to monitor the effects of a particular therapeutic intervention. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Leftover tissue will be asked for to be stored in the MPD-RC Tissue Bank
| Estimated Enrollment: | 860 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects enrolled in MPD-RC treatment protocols.
Criteria
Inclusion Criteria:
- Patients are to be registered to this study if they meet the eligibility criteria for one of the MPD-RC treatment protocols linked to this study.
- Patients diagnosed with the following Myeloproliferative disorders including: polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) who are participating in treatment protocols of the MPD-RC are eligible.
- Patients must have signed an informed consent to participate in a Myeloproliferative Disorders Research Consortium (MPD-RC) treatment study to which this protocol is a companion study. The subject must also have signed a consent to participate in this mandatory companion study.
Exclusion Criteria:
See inclusion criteria.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665067
Contacts
| Contact: Rona S Weinberg, PhD | (212) 570-3412 | rweinberg@nybloodcenter.org |
| Contact: Ronald Hoffman, MD | (212) 241-2297 | ronald.hoffman@mssm.edu |
Locations
| United States, Arizona | |
| Mayo Clinic | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Ruben Mesa, MD 480-301-8335 mesa.ruben@mayo.edu | |
| Principal Investigator: Ruben Mesa, MD | |
| United States, California | |
| The Palo Alto Clinic | Recruiting |
| Palo Alto, California, United States, 94301 | |
| Contact: David Liebowitz, MD 650-853-2905 leibowd@pamf.org | |
| Principal Investigator: David Liebowitz, MD | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20057 | |
| Principal Investigator: Craig Kessler, MD | |
| United States, Georgia | |
| Emory Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Elliot Winton, MD 404-778-5871 ewinton@emory.edu | |
| Principal Investigator: Elliot Winton, MD | |
| United States, Illinois | |
| University of Illinois at Chicago | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Principal Investigator: Damiano Rondelli, MD | |
| United States, Maryland | |
| Johns Hopkins Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21205-1911 | |
| Principal Investigator: Jerry L Spivak, MD | |
| University of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Maria Baer, MD 410-328-8708 mbaer@umm.edu | |
| Principal Investigator: Maria Baer, MD | |
| United States, New York | |
| New York Blood Center | Recruiting |
| New York, New York, United States, 60065 | |
| Contact: Rona S Weinberg, PhD 212-570-3412 rweinberg@nybloodcenter.org | |
| Principal Investigator: Rona S Weinberg, PhD | |
| Icahn School of Medicine at Mount Sinai | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: John Mascarenhas, MD 212-241-3417 john.mascarenhas@mssm.edu | |
| Principal Investigator: John Mascarenhas, MD | |
| Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10065 | |
| Principal Investigator: Tsiporah Shore, MD | |
| United States, North Carolina | |
| Wake Forest University Baptist Medical Center | Recruiting |
| Winston-salem, North Carolina, United States, 27157 | |
| Contact: Dmitry Berenzon, MD 336-716-5847 dberenzo@wfubmc.edu | |
| Principal Investigator: Dmitry Berenzon, MD | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Rebecca Klisovic, MD 614-293-4696 rebecca.klisovic@osumc.edu | |
| Principal Investigator: Rebecca Klisovic, MD | |
| United States, Pennsylvania | |
| Geisinger Cancer Center | Recruiting |
| Hazleton, Pennsylvania, United States, 18201 | |
| Contact: Paul Roda, MD 570-459-2901 proda1@geisinger.edu | |
| Principal Investigator: Paul Roda, MD | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Elizabeth Hexner, MD 215-662-4137 elizabeth.hexner@uphs.upenn.edu | |
| Principal Investigator: Elizabeth Hexner, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Principal Investigator: Josef Prachal, MD | |
| Italy | |
| Ospedali Riuniti di Bergamo | Recruiting |
| Bergamo, Italy | |
| Principal Investigator: Alessandro Rambaldi, MD | |
| University of Florence | Recruiting |
| Florence, Italy | |
| Principal Investigator: Allessandro Vannucchi, MD | |
| Ospedale San Martino Genova | Recruiting |
| Genova, Italy, 11632 | |
| Contact: Andrea Bacigalupo, MD 39 010-555469 andrea.bacigalupo@hsamartino.it | |
| Principal Investigator: Andrea Bacigalupo, MD | |
| San Matteo Hospital | Recruiting |
| Pavia, Italy, 27100 | |
| Contact: Gianni Barosi, MD 39-038-2503636 barosig@smateo.py.it | |
| Principal Investigator: Gianni Barosi, MD | |
| Sub-Investigator: Mario Cazzola, MD | |
| Universita Cattolica del Sacro Cuore | Recruiting |
| Rome, Italy, 00168 | |
| Contact: Giuseppe Leone, MD 39-063-0154180 gleone@rm.unicatt.it | |
| Principal Investigator: Giuseppe Leone, MD | |
| Sweden | |
| Vastra Gotalandsregionen | Recruiting |
| Gothenburg, Sweden | |
| Principal Investigator: Bjorn Andreasson, MD | |
| United Kingdom | |
| Guy's and St Thomas' NHS Foundation Trust | Not yet recruiting |
| London, United Kingdom, SE1 7EH | |
| Contact: Claire Harrison, MD 02 71882739 claire.harrison@gstt.sthames.nhs.uk | |
| Principal Investigator: Claire Harrison, MD | |
Sponsors and Collaborators
Mount Sinai School of Medicine
Myeloproliferative Disorders-Research Consortium
Investigators
| Study Chair: | Rona S Weinberg, PhD | Myeloproliferative Disorders-Research Consortium |
| Principal Investigator: | John Mascarenhas, MD | Icahn School of Medicine at Mount Sinai |
More Information
No publications provided
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00665067 History of Changes |
| Other Study ID Numbers: | GCO 07-0548-00107, P01CA108671-05, MPD-RC 107 |
| Study First Received: | April 21, 2008 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Myeloproliferative Disease Myelofibrosis Idiopathic Myelofibrosis Essential Thrombocythemia |
Polycythemia Vera Biomarkers Philadelphia Chromosome Negative Clonal Hematopoietic malignancies |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Myeloproliferative Disorders Philadelphia Chromosome Polycythemia Polycythemia Vera Thrombocythemia, Essential Thrombocytosis Bone Marrow Diseases |
Hematologic Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes Blood Coagulation Disorders Blood Platelet Disorders Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 16, 2013