Correlative Biomarker Study in Patients With Myeloproliferative Disorders
Correlative Biomarker Study for MPD-RC Treatment Studies in the Philadelphia Chromosome Negative MPD
3 other identifiers
observational
592
4 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 21, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2018
CompletedDecember 13, 2018
December 1, 2018
11.3 years
April 21, 2008
December 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
4 years
Eligibility Criteria
Subjects enrolled in MPD-RC treatment protocols.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
The Palo Alto Clinic
Palo Alto, California, 94301, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Emory Hospital
Atlanta, Georgia, 30322, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Weill Cornell Medical College
New York, New York, 10065, United States
New York Blood Center
New York, New York, 60065, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Ohio State University
Columbus, Ohio, 43210, United States
Geisinger Cancer Center
Hazleton, Pennsylvania, 18201, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Princess Margaret Cancer Centre
Toronto, Ontario, M5T 2M9, Canada
Ospedali Riuniti di Bergamo
Bergamo, Italy
University of Florence
Florence, Italy
Ospedale San Martino Genova
Genova, 11632, Italy
San Matteo Hospital
Pavia, 27100, Italy
Universita Cattolica del Sacro Cuore
Rome, 00168, Italy
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Biospecimen
Leftover tissue will be asked for to be stored in the MPD-RC Tissue Bank
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rona S Weinberg, PhD
Myeloproliferative Disorders-Research Consortium
- PRINCIPAL INVESTIGATOR
John Mascarenhas, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2008
First Posted
April 23, 2008
Study Start
April 1, 2007
Primary Completion
July 20, 2018
Study Completion
July 20, 2018
Last Updated
December 13, 2018
Record last verified: 2018-12