Correlative Biomarker Study in Patients With Myeloproliferative Disorders

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT00665067

Collaborator

Myeloproliferative Disorders-Research Consortium (Other), National Cancer Institute (NCI) (NIH)

592

Enrollment

Locations

135.6

Duration (Months)

26.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Myeloproliferative Disease Myelofibrosis Idiopathic Myelofibrosis Essential Thrombocythemia Polycythemia Vera

Study Design

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 :

Apr 1, 2007

Actual Primary Completion Date :

Jul 20, 2018

Actual Study Completion Date :

Jul 20, 2018

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Scottsdale	Arizona	United States	85259
2	The Palo Alto Clinic	Palo Alto	California	United States	94301
3	Georgetown University	Washington	District of Columbia	United States	20057
4	Emory Hospital	Atlanta	Georgia	United States	30322
5	University of Illinois at Chicago	Chicago	Illinois	United States	60612
6	University of Maryland	Baltimore	Maryland	United States	21201
7	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
8	Weill Cornell Medical College	New York	New York	United States	10065
9	New York Blood Center	New York	New York	United States	60065
10	Duke University Medical Center	Durham	North Carolina	United States	27705
11	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
12	Ohio State University	Columbus	Ohio	United States	43210
13	Geisinger Cancer Center	Hazleton	Pennsylvania	United States	18201
14	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
15	University of Utah	Salt Lake City	Utah	United States	84112
16	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5T 2M9
17	Ospedali Riuniti di Bergamo	Bergamo		Italy
18	University of Florence	Florence		Italy
19	Ospedale San Martino Genova	Genova		Italy	11632
20	San Matteo Hospital	Pavia		Italy	27100
21	Universita Cattolica del Sacro Cuore	Rome		Italy	00168
22	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