Correlative Biomarker Study in Patients With Myeloproliferative Disorders

December 12, 2018 updated by: Icahn School of Medicine at Mount Sinai

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5T 2M9
    - Princess Margaret Cancer Centre
Italy
- - Bergamo, Italy
    - Ospedali Riuniti di Bergamo
  - Florence, Italy
    - University of Florence
  - Genova, Italy, 11632
    - Ospedale San Martino Genova
  - Pavia, Italy, 27100
    - San Matteo Hospital
  - Rome, Italy, 00168
    - Universita Cattolica del Sacro Cuore
United Kingdom
- - London, United Kingdom, SE1 7EH
    - Guy's and St Thomas' NHS Foundation Trust
United States
- Arizona
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic
- California
  - Palo Alto, California, United States, 94301
    - The Palo Alto Clinic
- District of Columbia
  - Washington, District of Columbia, United States, 20057
    - Georgetown University
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory Hospital
- Illinois
  - Chicago, Illinois, United States, 60612
    - University of Illinois at Chicago
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland
- New York
  - New York, New York, United States, 10065
    - Weill Cornell Medical College
  - New York, New York, United States, 10029
    - Icahn School of Medicine at Mount Sinai
  - New York, New York, United States, 60065
    - New York Blood Center
- North Carolina
  - Durham, North Carolina, United States, 27705
    - Duke University Medical Center
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Baptist Medical Center
- Ohio
  - Columbus, Ohio, United States, 43210
    - Ohio State University
- Pennsylvania
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania
- Utah
  - Salt Lake City, Utah, United States, 84112
    - University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects enrolled in MPD-RC treatment protocols.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Cancer Institute (NCI)

Myeloproliferative Disorders-Research Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

July 20, 2018

Study Completion (ACTUAL)

July 20, 2018

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria