Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
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

Layout table for study information
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

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.


Layout table for eligibility information
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
Show Show 22 study locations
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Rona S Weinberg, PhD Myeloproliferative Disorders-Research Consortium
Principal Investigator: John Mascarenhas, MD Icahn School of Medicine at Mount Sinai
Layout table for additonal information
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00665067    
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:
Layout table for MeSH terms
Thrombocytosis
Thrombocythemia, Essential
Polycythemia Vera
Primary Myelofibrosis
Polycythemia
Myeloproliferative Disorders
Philadelphia Chromosome
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes