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Trial record 1 of 1 for:    Correlative Biomarker Study in Patients with Myeloproliferative Disorders
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Correlative Biomarker Study in Patients With Myeloproliferative Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00665067
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
Myeloproliferative Disorders-Research Consortium
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date April 21, 2008
First Posted Date April 23, 2008
Last Update Posted Date December 13, 2018
Study Start Date April 2007
Actual Primary Completion Date July 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlative Biomarker Study in Patients With Myeloproliferative Disorders
Official Title Correlative Biomarker Study for MPD-RC Treatment Studies in the Philadelphia Chromosome Negative MPD
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Leftover tissue will be asked for to be stored in the MPD-RC Tissue Bank
Sampling Method Non-Probability Sample
Study Population Subjects enrolled in MPD-RC treatment protocols.
Condition
  • Myeloproliferative Disease
  • Myelofibrosis
  • Idiopathic Myelofibrosis
  • Essential Thrombocythemia
  • Polycythemia Vera
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 12, 2018)
592
Original Estimated Enrollment
 (submitted: April 21, 2008)
860
Actual Study Completion Date July 20, 2018
Actual Primary Completion Date July 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Italy,   United Kingdom,   United States
Removed Location Countries Sweden
 
Administrative Information
NCT Number NCT00665067
Other Study ID Numbers GCO 07-0548-00107
P01CA108671-05 ( U.S. NIH Grant/Contract )
MPD-RC 107 ( Other Identifier: Myeloproliferative Disorders-Research Consortium )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor Icahn School of Medicine at Mount Sinai
Collaborators
  • 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
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date December 2018