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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00378-31 | Other Identifier | ID RCB | |
| B100413-10 | Other Identifier | AFSSAPS | |
| 10/16-758 | Other Identifier | CPP Rennes |
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Blood circulating endothelial cells (CEC) and microparticles (MPs) are described in the literature to be associated with vascular failures and dysfunction that reflect neo-angiogenesis and risk of thrombosis, respectively. There a few number of CEC in healthy patients although they significantly increase in several cancers including myeloma. However, no study explored to date a correlation of CEC and/or circulating endothelial progenitors (CEP) and MPs with the tumoral growth of monoclonal gammopathy. On the other hand, there is no study measuring the CEC and CEP directly in the bone marrow. The investigators aim is to evaluate these 2 original features in patients with monoclonal gammopathy: monoclonal gammopathy of undetermined signification (MGUS) and myeloma. This is a preliminary multicentric study.
Principal objective : Research of a correlation of blood CEC and MPs with the tumoral volume and the clinico-biological staging of monoclonal gammopathies.
Secondary objectives : Research of a correlation of bone marrow endothelial cells and MPs, both measured by flow cytometry, with the tumoral volume and the clinico-biological staging of monoclonal gammopathies.
Principal analyses : Blood levels of CEC and its progenitors, soluble parameters of angiogenesis and of coagulability, and microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).
Secondary analyses : Bone marrow levels of endothelial cells and its progenitors, soluble parameters of angiogenesis and of coagulability, and microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).
Methodology : PACMoG is an interventional, prospective and multicentric pilot study. Biologic parameters will be determined at the diagnosis of monoclonal gammopathy. Results will be compared to the monoclonal gammopathy international staging and the clinical follow-up.
Procedures : Specific tests of the study will be realized from :
In all cases, no additional sampling will be performed.
Specific analyses :
- Specific biological assays in blood and bone marrow will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monoclonal gamopathy | Experimental | Patients with monoclonal gammopathy either MGUS or myeloma at diagnosis or more than 3 months after a first myeloma treatment with chemotherapy and/or antiangiogenic drugs.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood and bone marrow samples | Other | Specific tests of the study will be realized from :
In all cases, no additional sampling will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of CEC and its progenitors | Blood levels of CEC and its progenitors | Day 1 |
| Blood levels of soluble parameters of angiogenesis and of coagulability | Blood levels of soluble parameters of angiogenesis and of coagulability | Day 1 |
| Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak). | Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Bone marrow levels of endothelial cells and its progenitors | Bone marrow levels of endothelial cells and its progenitors | Day 1 |
| Bone Marrow levels of soluble parameters of angiogenesis and of coagulability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoît GUILLET, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | Brittany Region | 35033 | France |
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| ID | Term |
|---|---|
| D010265 | Paraproteinemias |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
| Day 1 |
| Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak). | Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak). | Day 1 |
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |