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Correlative Biomarker Study in Patients With Myeloproliferative Disorders

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ClinicalTrials.gov Identifier: NCT00665067
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
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
Actual Enrollment : 592 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
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018





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

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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.
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.


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 ClinicalTrials.gov identifier (NCT number): NCT00665067


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
The Palo Alto Clinic
Palo Alto, California, United States, 94301
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Georgia
Emory Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Weill Cornell Medical College
New York, New York, United States, 10065
New York Blood Center
New York, New York, United States, 60065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Geisinger Cancer Center
Hazleton, Pennsylvania, United States, 18201
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5T 2M9
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy
University of Florence
Florence, Italy
Ospedale San Martino Genova
Genova, Italy, 11632
San Matteo Hospital
Pavia, Italy, 27100
Universita Cattolica del Sacro Cuore
Rome, Italy, 00168
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Investigators
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
ClinicalTrials.gov 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: December 13, 2018
Last Verified: December 2018

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

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