NCT01970930

Brief Summary

The purpose of the study is to isolate and characterize stem cells of patients with Polycythemia Vera (PV) and Essential Thrombocythemia (ET) to find out why these cells are not working the way they should be and why they seem to be sensitive to regulatory factors in the blood, such as clotting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

August 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2016

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

August 20, 2013

Last Update Submit

January 17, 2018

Conditions

Polycythemia VeraEssential Thrombocythemia

Keywords

Tissue banking

Outcome Measures

Primary Outcomes (1)

  • Stem cell function

    Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.

    at one time study visit

Secondary Outcomes (1)

  • CD34+ cells assays

    at one time study visit

Study Arms (1)

PV or ET

subject who has polycythemia vera or essential thrombocythemia

Procedure: Blood specimen

Interventions

Blood specimenPROCEDURE

4 green top tube 40 cc of blood draw

PV or ET

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have polycythemia vera or essential thrombocythemia

You may qualify if:

  • polycythemia vera or essential thrombocythemia
  • agree to give blood for study

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CD34+ cells isolated from the peripheral blood Splenic CD34+ cells

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, Essential

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative DisordersBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ronald Hoffman, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 20, 2013

First Posted

October 28, 2013

Study Start

August 1, 2012

Primary Completion

June 2, 2016

Study Completion

June 2, 2016

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

US(1)