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Trial record 14 of 1808 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Diagnostic Value of Bone Marrow Tryptase in Systemic Mastocytosis (EvaTryMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02441166
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : August 14, 2018
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

The hypothesis of the study is that Bone Marrow Tryptase (MT) level is a diagnostic marker of Systemic Mastocytosis (SM). Determination of the bone marrow tryptase in Bone Marrow Aspirate (BMA) could be a new diagnostic criteria for systemic mastocytosis with sensitivity close to 100% and a low false negative rate. This new test could be useful to improve the ability to diagnose accurately systemic mastocytosis (in particular the indolent forms). Because of its limited invasiveness compared to bone marrow biopsy, it could also be considered as a test performed before bone marrow biopsy. Only patients with high bone marrow tryptase would then undergo bone marrow biopsy.

In the future and if validated by this study, bone marrow tryptase could be a useful marker of mast cell load and help to monitor the efficacy of treatment in systemic mastocytosis.

Condition or disease Intervention/treatment Phase
Systemic Mastocytosis Procedure: Mastocytosis diagnosis Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Diagnostic Value of Level of Bone Marrow Tryptase in Adult Systemic Mastocytosis
Actual Study Start Date : October 6, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Mastocytosis diagnosis
For each enrolled subject, 5 mL sample of peripheral blood and 1 mL sample of BM aspirate will be collected the same day to do diagnosis mastocytosis tests (quantification of the kit mutations by qPCR, plasma tryptase level, immunophenotyping of BM mastocytes by flow cytometry, BM tryptase level, degree of dilution of the BM aspirate...) using the WHO criteria as the reference standard.
Procedure: Mastocytosis diagnosis
Some samples will be extracted from bone marrow aspirate and peripheral blood on the inclusion day to do diagnosis tests. WHO criteria will be used as the reference standard.

Primary Outcome Measures :
  1. Bone marrow tryptase level [ Time Frame: Day 4 after bone marrow aspiration ]
    Aliquot of the bone marrow aspirate sample will be used after centrifugation for measurements of bone marrow tryptase level.

Secondary Outcome Measures :
  1. The bone marrow tryptase level for differential diagnosis between systemic mastocytosis and cell mast activation syndrome [ Time Frame: Day 4 after bone marrow aspiration ]
    Aliquot of the bone marrow aspirate sample will be used after centrifugation for measurements of bone marrow tryptase level.

  2. The bone marrow tryptase/serum tryptase ratio for diagnosis of systemic mastocytosis with and without mastocytosis in skin [ Time Frame: Day 4 after bone marrow aspiration ]
  3. The absolute and corrected bone marrow tryptase level for diagnosis of systemic mastocytosis with and without mastocytosis in skin [ Time Frame: Day 4 after bone marrow aspiration ]
    The degree of dilution of the bonne marrow aspirate by peripheral blood will be estimated by comparing the percentage of CD16bright vs CD16low granulocytes in bone marrow samples and used to adjust the bone marrow tryptase.

  4. Flow cytometry performed on cells collected by bone marrow aspirate and maintained in a preservative solution (TransFix®) to detect mast cells expressing CD25 and/or CD2 for diagnosis of systemic mastocytosis with and without mastocytosis in skin [ Time Frame: Day 4 after bone marrow aspiration ]
    Immunophenotyping of bone marrow mastocytes will be performed on bone marrow aspiration stabilized by Transfix using a pre-defined mixture of anti-CD45/CD117/CD34/CD2/CD25/CD16 antibodies.

  5. Quantification of KIT mutations-positive cells fraction in peripheral blood for systemic mastocytosis diagnosis,correlation with results of medullar tryptase level, medullar/systemic tryptase ratio and absolute and corrected medullar tryptase level [ Time Frame: Day 4 after bone marrow aspiration ]
    Genomic DNA from total leucocytes will be purified from the peripheral blood samples and used for the quantification of the kit mutation by qPCR

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Suspicion of systemic mastocytosis, for whom bone marrow sampling (bone marrow biopsy and/or bone marrow aspiration) is carried out as part of normal workup of the disease in the center of reference and centers of competence in mastocytosis.
  • Patient whose written informed consent has been obtained.

Exclusion Criteria:

  • Patients with a contra-indication to marrow sampling (anticoagulant and/or anti-clotting treatments,
  • Thrombocytopenia < 50 000/mm2) for whom it is impossible to formally conclude the final type of mast cell disease: SM, CM, mast cell activation syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02441166

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Contact: Cristina Livideanu, MD 05 67 77 81 35 ext 33

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CHU Bordeaux Hôpital Haut-Lévêque, service de dermatologie Recruiting
Bordeaux, France
Contact: Marie Beylot-Barry, MD   
Principal Investigator: Marie Beylot-Barry         
CHU de Caen, service d'hématologie Recruiting
Caen, France
Contact: Ghandi Damaj, MD   
Principal Investigator: Ghandi Damaj, MD         
CHU Dupuytren service d'hématologie Recruiting
Limoges, France
Contact: Marie-Pierre Gourin, MD   
Principal Investigator: Marie-Pierre Gourin, MD         
CHU Lyon Sud, service de médecine interne Recruiting
Lyon, France
Contact: Stéphane Durupt, MD   
Principal Investigator: Stéphane Durupt, MD         
Hôpital Necker, service d'hématologie Recruiting
Paris, France
Contact: Marie-Olivia Chandesris, MD   
Principal Investigator: Marie-Olivia Chandesris, MD         
Hôpital Pité Salpétrière Recruiting
Paris, France
Contact: Stéphane Barete, MD   
CHU Toulouse, Hôpital Larrey, service de dermatologie Recruiting
Toulouse, France
Contact: Cristina Livideanu, MD   
Principal Investigator: Cristina Livideanu         
CHU Fort de France, service de dermatologie Recruiting
Fort-de-France, Martinique
Contact: Emilie Baubion, MD   
Principal Investigator: Emilie Baubion, MD         
Sponsors and Collaborators
University Hospital, Toulouse
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Principal Investigator: Cristina Livideanu, MD CHU Toulouse


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Responsible Party: University Hospital, Toulouse Identifier: NCT02441166     History of Changes
Other Study ID Numbers: RC31/14/7387
2015-A00351-48 ( Other Identifier: Id-RCB number )
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Keywords provided by University Hospital, Toulouse:
Bone marrow tryptase
cutaneous mastocytosis

Additional relevant MeSH terms:
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Mastocytosis, Systemic
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Skin Diseases
Immune Complex Diseases
Immune System Diseases