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Trial record 1 of 1 for:    Study allows for the preservation and storage of a small portion of tissues to be used for the study of MPDs.
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Research Tissue Bank

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ClinicalTrials.gov Identifier: NCT00666549
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : July 5, 2019
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 23, 2008
First Posted Date April 25, 2008
Last Update Posted Date July 5, 2019
Study Start Date September 2007
Actual Primary Completion Date March 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2008)
To collect and store tissue specimens from patients with MPDs including PV, IM, ET. The samples will be used to conduct laboratory investigations to help define mechanisms involved in the pathophysiology and treatment of these disorders. [ Time Frame: 3 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 Research Tissue Bank
Official Title Research Tissue Bank
Brief Summary

This study that will allow for the preservation and/or storage of a small portion one or more of the following tissues:

  • Peripheral blood
  • Bone marrow
  • Bone marrow biopsy
  • A phlebotomized unit of blood
  • Spleen cells
  • Toenail clippings

This material will be used for the study of Myeloproliferative Disorders (MPD) by researchers. The goals of this research study are to understand the causes of MPDs, how to diagnose them more easily and how to treat them better. MPD is a disease affecting hematopoietic stem cells. Hematopoietic stem cells are cells that make blood cells. These stem cells grow in the center portion of the bones called bone marrow. Under some conditions, these cells are also found in blood. There are several diseases, which are classified as MPD. These include polycythemia vera (too many red blood cells), essential thrombocythemia (too many platelets), and idiopathic myelofibrosis (abnormal blood cells and fibers build up in the bone marrow). 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.

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:
Blood, bone marrow, bone marrow biopsy, toenail clippings, phlebotomized blood, spleen cells
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible and not currently participating in any MPD-RC treatment studies.
Condition
  • 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: July 2, 2019)
963
Original Estimated Enrollment
 (submitted: April 24, 2008)
400
Actual Study Completion Date March 27, 2017
Actual Primary Completion Date March 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible.
  • Newly diagnose MPD patients as well as previously treated for a MPD are eligible.
  • Signed informed consent is required from each patient at the time of enrollment.

Exclusion Criteria:

  • Patients currently participating in experimental treatment arms of MPD-RC protocols, or other experimental treatment protocols are not eligible during the period they are on study.
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 Italy,   United States
Removed Location Countries Sweden
 
Administrative Information
NCT Number NCT00666549
Other Study ID Numbers GCO 07-0548-00106
P01CA108671-01A2 ( U.S. NIH Grant/Contract )
MPD-RC 106 ( 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: Lewis Silverman, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date July 2019