Correlative Biomarker Study in Patients With Myeloproliferative Disorders

Completed

• Conditions: Polycythemia Vera; Myeloproliferative Disease; Myelofibrosis; Idiopathic Myelofibrosis; Essential Thrombocythemia

• Registration Number: NCT00665067
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-23
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (22)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Emory Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Florence; 🇮🇹 Florence, Italy

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

The Palo Alto Clinic; 🇺🇸 Palo Alto, California, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

New York Blood Center; 🇺🇸 New York, New York, United States

Universita Cattolica del Sacro Cuore; 🇮🇹 Rome, Italy

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Geisinger Cancer Center; 🇺🇸 Hazleton, Pennsylvania, United States

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Ospedale San Martino Genova; 🇮🇹 Genova, Italy

San Matteo Hospital; 🇮🇹 Pavia, Italy

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom