Polycythemia VeraNCT01970930
Tissue Banking Study - Polycythemia Vera or Essential Thrombocythemia (PV & ET) Patients
An observational study of Polycythemia Vera and Essential Thrombocythemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polycythemia Vera, Essential Thrombocythemia
- What is being tested?
- Blood specimen
- Type of treatment
- Surgery or procedure
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 2 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have polycythemia vera or essential thrombocythemia
Who may be able to join
- polycythemia vera or essential thrombocythemia
- agree to give blood for study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53
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.
Read the detailed description
Specific Aim 1: Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.
Specific Aim 2. Assess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC.
- Conditions
- Polycythemia Vera, Essential Thrombocythemia
- Being tested
- Blood specimen
- Keywords
- Tissue banking
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood specimenProcedure or surgery
4 green top tube 40 cc of blood draw
| Study group | Role | What they receive |
|---|---|---|
| PV or ET | subject who has polycythemia vera or essential thrombocythemia Receives: Procedure: Blood specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem cell function
Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.
Measured: at one time study visit
Secondary outcomes (1)
CD34+ cells assays
Assess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC. After treatment with RG7112 and IFNα at the various doses, p53, MDM2, MDMX, phosphor-p38, and phosphor-STAT1 levels in MPN CD34+ cells will be measured using monoclonal antibody staining and flow cytometric and immunofluorescence analyses.
Measured: at one time study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startAug 2012
- Primary completion2 Jun 2016
- Study completion2 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society
- Responsible party
- Sponsor
- Investigators
- Ronald Hoffman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970930
- Sponsor's protocol ID
- GCO 12-0481
- Status last verified
- Jan 2018
- First submitted
- 20 Aug 2013
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53
- ClinicalTrials.gov ID
- NCT01970930
- Acronym / sponsor ID
- GCO 12-0481
- Conditions
- Polycythemia Vera, Essential Thrombocythemia
- Keywords
- Tissue banking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society
- Study start
- Aug 2012
- Primary completion
- 2 Jun 2016 (actual)
- Study completion
- 2 Jun 2016 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aim 1: Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.
Specific Aim 2. Assess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PV or ET | – | Procedure: Blood specimensubject who has polycythemia vera or essential thrombocythemia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have polycythemia vera or essential thrombocythemia
Key inclusion criteria (2 listed)
- polycythemia vera or essential thrombocythemia
- agree to give blood for study
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood specimen4 green top tube 40 cc of blood draw | Procedure or surgery | PV or ET |
Primary outcome
Stem cell function
Time frame: at one time study visit
Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.
1 secondary outcome
CD34+ cells assays
Time frame: at one time study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Hoffman, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia Vera and Essential Thrombocythemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stem cell function (time frame: at one time study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.