Skip to main content
OpenTrials
Completed

NCT Number: NCT01543100

Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Monoclonal Gammopathy Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Monoclonal Gammopathy of Undetermined Signification Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, Brittany Region, 35033, France

About this 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 :

  • Blood samples: 2 EDTA tubes and 1 tube without anticoagulant per included patient.
  • Bone marrow: 3 ml collected during of myelogram punction made for the diagnosis.

In all cases, no additional sampling will be performed.

Specific analyses :

  • Specific biological assays in blood and bone marrow will be:
  • Endothelial and progenitor cells levels
  • Number and cellular origin of MPSs
  • Levels of phospholipid-dependant coagulability
  • Soluble parameters of angiogenesis (VEGF, soluble CD146, endostatin)
  • Soluble parameters of coagulability (Levels of thrombomodulin, tissue factor and D-Dimer)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patient's age ≥ 18 years old,
  • Patients having signed the specific consent of the study.

Exclusion criteria

  • Treatment with chemotherapy and/or antiangiogenic drugs at the inclusion
  • Age < 18 years old
  • No specific consent of the study

Treatment and study plan

blood and bone marrow samples

Other

Specific tests of the study will be realized from :

  • Blood samples: 2 EDTA tubes and 1 tube without anticoagulant per included patient.
  • Bone marrow: 3 ml collected during of myelogram punction made for the diagnosis.

In all cases, no additional sampling will be performed.

Primary outcomes

  1. Blood levels of CEC and its progenitors

    Time frame: Day 1

    Blood levels of CEC and its progenitors

  2. Blood levels of soluble parameters of angiogenesis and of coagulability

    Time frame: Day 1

    Blood levels of soluble parameters of angiogenesis and of coagulability

  3. Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).

    Time frame: Day 1

    Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).

Secondary outcomes

  1. Bone marrow levels of endothelial cells and its progenitors

    Time frame: Day 1

    Bone marrow levels of endothelial cells and its progenitors

  2. Bone Marrow levels of soluble parameters of angiogenesis and of coagulability

    Time frame: Day 1

    Bone Marrow levels of soluble parameters of angiogenesis and of coagulability

  3. Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).

    Time frame: Day 1

    Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: PACMoG

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 2, 2012
Registry last updated
Jan 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.