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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00665067
Other study ID # GCO 07-0548-00107
Secondary ID P01CA108671-05MP
Status Completed
Phase
First received
Last updated
Start date April 2007
Est. completion date July 20, 2018

Study information

Verified date December 2018
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 592
Est. completion date July 20, 2018
Est. primary completion date July 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario
Italy Ospedali Riuniti di Bergamo Bergamo
Italy University of Florence Florence
Italy Ospedale San Martino Genova Genova
Italy San Matteo Hospital Pavia
Italy Universita Cattolica del Sacro Cuore Rome
United Kingdom Guy's and St Thomas' NHS Foundation Trust London
United States Emory Hospital Atlanta Georgia
United States University of Maryland Baltimore Maryland
United States University of Illinois at Chicago Chicago Illinois
United States Ohio State University Columbus Ohio
United States Duke University Medical Center Durham North Carolina
United States Geisinger Cancer Center Hazleton Pennsylvania
United States Icahn School of Medicine at Mount Sinai New York New York
United States New York Blood Center New York New York
United States Weill Cornell Medical College New York New York
United States The Palo Alto Clinic Palo Alto California
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of Utah Salt Lake City Utah
United States Mayo Clinic Scottsdale Arizona
United States Georgetown University Washington District of Columbia
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai Myeloproliferative Disorders-Research Consortium, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Italy,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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