Correlative Biomarker Study in Patients With Myeloproliferative Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Mount Sinai School of Medicine
Sponsor:
Collaborators:
Myeloproliferative Disorders-Research Consortium
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00665067
First received: April 21, 2008
Last updated: February 27, 2013
Last verified: February 2013

April 21, 2008
February 27, 2013
April 2007
December 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00665067 on ClinicalTrials.gov Archive Site
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Correlative Biomarker Study in Patients With Myeloproliferative Disorders
Correlative Biomarker Study for MPD-RC Treatment Studies in the Philadelphia Chromosome Negative MPD

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.

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Observational
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Retention:   Samples With DNA
Description:

Leftover tissue will be asked for to be stored in the MPD-RC Tissue Bank

Non-Probability Sample

Subjects enrolled in MPD-RC treatment protocols.

  • Myeloproliferative Disease
  • Myelofibrosis
  • Idiopathic Myelofibrosis
  • Essential Thrombocythemia
  • Polycythemia Vera
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
860
December 2015
December 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Rona S Weinberg, PhD (212) 570-3412 rweinberg@nybloodcenter.org
Contact: Ronald Hoffman, MD (212) 241-2297 ronald.hoffman@mssm.edu
United States,   Italy,   Sweden,   United Kingdom
 
NCT00665067
GCO 07-0548-00107, P01CA108671-05, MPD-RC 107
Yes
Mount Sinai School of Medicine
Mount Sinai School of Medicine
  • Myeloproliferative Disorders-Research Consortium
  • National Cancer Institute (NCI)
Study Chair: Rona S Weinberg, PhD Myeloproliferative Disorders-Research Consortium
Principal Investigator: John Mascarenhas, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP