Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Correlative Biomarker Study in Patients With Myeloproliferative Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Mount Sinai School of Medicine
Sponsor:
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: August 13, 2014
Last verified: August 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Principal Investigator: Tsiporah Shore, MD         
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         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Murat Arcasoy, MD    919-668-6309    arcas001@mc.duke.edu   
Principal Investigator: Murat Arcasoy, MD         
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: Harsh Gandhi, MD    570-459-2901    hgandhi1@geisinger.edu   
Principal Investigator: Harsh Gandhi, 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         
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5T 2M9
Contact: Vikas Gupta, MD    416-946-6546    Vikas.Gupta@uhn.on.ca   
Principal Investigator: Vikas Gupta, 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         
United Kingdom
Guy's and St Thomas' NHS Foundation Trust 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 Mount Sinai School of Medicine
  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: August 13, 2014
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:
Myeloproliferative Disorders
Philadelphia Chromosome
Polycythemia
Polycythemia Vera
Primary Myelofibrosis
Thrombocythemia, Essential
Thrombocytosis
Blood Coagulation Disorders
Blood Platelet Disorders
Bone Marrow Diseases
Chromosome Aberrations
Hematologic Diseases
Hemorrhagic Disorders
Pathologic Processes
Translocation, Genetic

ClinicalTrials.gov processed this record on November 25, 2014