Correlative Biomarker Study in Patients With Myeloproliferative Disorders

NCT ID: NCT00665067

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

592 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2018-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Myeloproliferative Disease Myelofibrosis Idiopathic Myelofibrosis Essential Thrombocythemia Polycythemia Vera

Keywords

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Myeloproliferative Disease Myelofibrosis Idiopathic Myelofibrosis Essential Thrombocythemia Polycythemia Vera Biomarkers Philadelphia Chromosome Negative Clonal Hematopoietic malignancies

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myeloproliferative Disorders-Research Consortium

NETWORK

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rona S Weinberg, PhD

Role: STUDY_CHAIR

Myeloproliferative Disorders-Research Consortium

John Mascarenhas, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

The Palo Alto Clinic

Palo Alto, California, United States

Site Status

Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Emory Hospital

Atlanta, Georgia, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

New York Blood Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Geisinger Cancer Center

Hazleton, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Ospedali Riuniti di Bergamo

Bergamo, , Italy

Site Status

University of Florence

Florence, , Italy

Site Status

Ospedale San Martino Genova

Genova, , Italy

Site Status

San Matteo Hospital

Pavia, , Italy

Site Status

Universita Cattolica del Sacro Cuore

Rome, , Italy

Site Status

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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Sweden United States Canada Italy United Kingdom

Other Identifiers

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P01CA108671-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MPD-RC 107

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 07-0548-00107

Identifier Type: -

Identifier Source: org_study_id