Correlative Biomarker Study in Patients With Myeloproliferative Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00665067
Recruitment Status : Recruiting
First Posted : April 23, 2008
Last Update Posted : October 5, 2017
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:

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 or disease
Myeloproliferative Disease Myelofibrosis Idiopathic Myelofibrosis Essential Thrombocythemia Polycythemia Vera

Study Type : Observational
Estimated Enrollment : 860 participants
Observational Model: Other
Time Perspective: Other
Official Title: Correlative Biomarker Study for MPD-RC Treatment Studies in the Philadelphia Chromosome Negative MPD
Study Start Date : April 2007
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Leftover tissue will be asked for to be stored in the MPD-RC Tissue Bank

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects enrolled in MPD-RC treatment protocols.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00665067

Contact: Rona S Weinberg, PhD (212) 570-3412
Contact: Ronald Hoffman, MD (212) 241-2297

United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Ruben Mesa, MD    480-301-8335   
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   
Principal Investigator: David Liebowitz, MD         
United States, District of Columbia
Georgetown University Recruiting
Washington, D.C., 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   
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   
Principal Investigator: Maria Baer, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: John Mascarenhas, MD    212-241-3417   
Principal Investigator: John Mascarenhas, MD         
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   
Principal Investigator: Rona S Weinberg, PhD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Murat Arcasoy, MD    919-668-6309   
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   
Principal Investigator: Dmitry Berenzon, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Rebecca Klisovic, MD    614-293-4696   
Principal Investigator: Rebecca Klisovic, MD         
United States, Pennsylvania
Geisinger Cancer Center Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Harsh Gandhi, MD    570-459-2901   
Principal Investigator: Harsh Gandhi, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Hexner, MD    215-662-4137   
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   
Principal Investigator: Vikas Gupta, MD         
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   
Principal Investigator: Andrea Bacigalupo, MD         
San Matteo Hospital Recruiting
Pavia, Italy, 27100
Contact: Gianni Barosi, MD    39-038-2503636   
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   
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   
Principal Investigator: Claire Harrison, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Study Chair: Rona S Weinberg, PhD Myeloproliferative Disorders-Research Consortium
Principal Investigator: John Mascarenhas, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT00665067     History of Changes
Other Study ID Numbers: GCO 07-0548-00107
P01CA108671-05 ( U.S. NIH Grant/Contract )
MPD-RC 107 ( Other Identifier: Myeloproliferative Disorders-Research Consortium )
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by Icahn School of Medicine at Mount Sinai:
Myeloproliferative Disease
Idiopathic Myelofibrosis
Essential Thrombocythemia
Polycythemia Vera
Philadelphia Chromosome Negative
Clonal Hematopoietic malignancies

Additional relevant MeSH terms:
Thrombocythemia, Essential
Primary Myelofibrosis
Polycythemia Vera
Philadelphia Chromosome
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes