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Myeloproliferative DisordersSMPNCT00873574

JAK-STAT Signalling Pathway in Familial Myeloproliferative Disorders

An observational study of Myeloproliferative Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Myeloproliferative Disorders
What is being tested?
Blood samples and buccal swabs
How many people
234 participants
Where
1 siteFrance
Study dates
Sep 2008to Sep 2012
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Population of familial patients with MPD and controls

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Department of Hematology, Hospital Saint Antoine

    Paris, 75012

Other trials in France

About this study

Official title: Molecular Study of Factors Involved in JAK-STAT Signalling Pathway in Familial Myeloproliferative Disorders

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

Read the detailed description

Myeloproliferative disorders (MPD) are rare malignant diseases of the bone marrow characterized by a proliferation of differentiated blood cells during a long time and a possible transformation in an acute leukaemia.

The recent identification of a recurrent activating tyrosine kinase mutation V617F in the JAK2 gene provides a breakthrough in the understanding of the molecular mechanisms of these diseases. It can't explain nevertheless the phenotypic diversity of MPD and the occurrence of familial aggregations. The investigators have shown actually that the mutation V617F is a somatic one which is variably expressed among patients in the same family.Other somatic mutations and inherited factors, still unknown, may explain these discrepancies. JAK-STAT pathway has an essential role in non-CML MPD as was shown by the functional consequences of the V617F JAK2 mutation. Therefore, the investigators will focus our study on the genes encoding factors implicated in this signalling pathway. Two genetic approaches will be used: 1-study of known polymorphisms (SNP) of theses genes involved in the JAK-STAT pathway; 2-search of rare mutations located in specific regions (binding domain…) of candidate genes.The study is a national multicenter research based on the national network (55 centers) that the investigators have organized with the help of the French Society Of Hematology in 1998. The investigators propose to include 120 families defined by the presence of at least 2 cases of non CML MPD (WHO and PVSG criteria).The investigators have already collected 60 families (affected cases and control subject); the other 60 will be included in the next two years. In each family, only the two patients with MPD and one control will be included ( all the subjects above 18 years old). Peripheral blood samples (35ml) and buccal swabs will be collected for each subject. Hematologists and ONCOGENETICIANS will include the families, collect all the clinical and biological data and perform the collection of biological material from each subject included in the study according to approved rules.All the data will be anonymously registered on Access data base. Hematological studies will be done in the Immuno-Hematological Laboratory in Saint ANTOINE. Genetic studies will be conducted in the Genetic Department of Saint ANTOINE Hospital now transferred to Pitie-Salpetriere Hospital in Paris. The genetic study will be based on the analysis of 120 unrelated familial SMP cases (randomised) and 120 controls. The investigators will study 10 genes involved in the JAK-STAT pathway ( cytokine receptors, Janus kinases, regulatory factors).The genotyping of SNPs, selected from HAPMAP and CGEMS databases will be performed by quantitative PCR. The investigators plan to analyze 50 SNPs per subject i.e. 24000 genotypes (duplicate points). The analysis will be based on the allelic frequency comparison in the two groups using a bilateral paired t-test; 120 pairs of subjects (case control) allow to detect a 0.6 deviation standard of allelic frequency between cases and controls (alpha = 5%, beta = 10%). The search for rare mutations will be done by genomic sequencing of particular regions in candidates genes in the 120 affected cases.

Being tested
Blood samples and buccal swabs
Keywords
Familial myeloproliferative disorders, JAK-STAT, V617, JAK2
Medical subject headings
Myeloproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samples and buccal swabsBiological

    Peripheral blood samples (35 ml) and buccal swabs

Study groups in NCT00873574
Study groupRoleWhat they receive
12 patients with MPD for each family. One case for each family will be randomised ; the cohort will be of 120 patients.
Receives: Biological: Blood samples and buccal swabs
21 control for each family
Receives: Biological: Blood samples and buccal swabs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Allelic frequency comparison between the 2 cohorts

    Measured: At the inclusion visit

Secondary outcomes (1)
  1. Undescribed gene mutations.

    Measured: At the inclusion visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionMay 2011
  4. Study completionSep 2012

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00873574
Sponsor's protocol ID
AOR 07014
Acronym
SMP
Status last verified
Mar 2013
First submitted
31 Mar 2009
Last updated
8 Mar 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myeloproliferative Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 4 inclusion and 2 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 8 Mar 2013. 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 France. 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?

Allelic frequency comparison between the 2 cohorts (time frame: At the inclusion 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 8 Mar 2013.

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