Myelofibrosis Clinical Trial
Official title:
Correlative Biomarker Study for MPD-RC Treatment Studies in the Philadelphia Chromosome Negative MPD
| Verified date | December 2018 |
| Source | Icahn School of Medicine at Mount Sinai |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 592 |
| Est. completion date | July 20, 2018 |
| Est. primary completion date | July 20, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
| Italy | Ospedali Riuniti di Bergamo | Bergamo | |
| Italy | University of Florence | Florence | |
| Italy | Ospedale San Martino Genova | Genova | |
| Italy | San Matteo Hospital | Pavia | |
| Italy | Universita Cattolica del Sacro Cuore | Rome | |
| United Kingdom | Guy's and St Thomas' NHS Foundation Trust | London | |
| United States | Emory Hospital | Atlanta | Georgia |
| United States | University of Maryland | Baltimore | Maryland |
| United States | University of Illinois at Chicago | Chicago | Illinois |
| United States | Ohio State University | Columbus | Ohio |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Geisinger Cancer Center | Hazleton | Pennsylvania |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | New York Blood Center | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | The Palo Alto Clinic | Palo Alto | California |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of Utah | Salt Lake City | Utah |
| United States | Mayo Clinic | Scottsdale | Arizona |
| United States | Georgetown University | Washington | District of Columbia |
| United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Icahn School of Medicine at Mount Sinai | Myeloproliferative Disorders-Research Consortium, National Cancer Institute (NCI) |
United States, Canada, Italy, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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