NCT00873574

Brief Summary

The main goal of the study is to progress in our understanding of the molecular basis of myeloproliferative disorders of the bone marrow (polycythemia vera, essential thrombocythemia, primary myelofibrosis). The study will focus on the genes encoding factors implicated in the JAK-STAT pathway which has an essential role in these diseases

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

2.7 years

First QC Date

March 31, 2009

Last Update Submit

March 7, 2013

Conditions

Myeloproliferative Disorders

Keywords

Familial myeloproliferative disordersJAK-STATV617JAK2

Outcome Measures

Primary Outcomes (1)

  • Allelic frequency comparison between the 2 cohorts

    At the inclusion visit

Secondary Outcomes (1)

  • Undescribed gene mutations.

    At the inclusion visit

Study Arms (2)

1

2 patients with MPD for each family. One case for each family will be randomised ; the cohort will be of 120 patients.

Biological: Blood samples and buccal swabs

2

1 control for each family

Biological: Blood samples and buccal swabs

Interventions

Blood samples and buccal swabsBIOLOGICAL

Peripheral blood samples (35 ml) and buccal swabs

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population of familial patients with MPD and controls

You may qualify if:

  • Patients affected with polycythemia vera, essential thrombocythemia or primary myelofibrosis
  • Familial cases
  • Subjects above 18 years old
  • Non affected controls

You may not qualify if:

  • patients with chronic myeloid leukaemia
  • subjects under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Hospital Saint Antoine

Paris, 75012, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples (35 ml) and buccal swabs

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Albert NAJMAN, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

September 1, 2008

Primary Completion

May 1, 2011

Study Completion

September 1, 2012

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

FR(1)