NCT00666549

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
963

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2017

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

9.6 years

First QC Date

April 23, 2008

Last Update Submit

July 2, 2019

Conditions

Keywords

Myeloproliferative DiseaseMyelofibrosisIdiopathic MyelofibrosisEssential ThrombocythemiaPolycythemia Vera

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

Weill Cornell University

Washington D.C., District of Columbia, 10065, United States

Location

University of Georgetown

Washington D.C., District of Columbia, 20057, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

University of Utah

Salt Lake City, Utah, 84102, United States

Location

Ospedali Riuniti di Bergamo

Bergamo, IL, Italy

Location

University of Florence

Florence, IL, 60302, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, bone marrow, bone marrow biopsy, toenail clippings, phlebotomized blood, spleen cells

MeSH Terms

Conditions

Primary MyelofibrosisThrombocythemia, EssentialPolycythemia VeraMyeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic DisordersBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Rona S Weinberg, PhD

    Myeloproliferative Disorders-Research Consortium

    STUDY CHAIR
  • Lewis Silverman, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

September 1, 2007

Primary Completion

March 27, 2017

Study Completion

March 27, 2017

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations