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Familial Dysglobulinemia (PreFamDys)

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: NCT02853214
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : July 29, 2020
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown and no lifestyle or environmental exposure factors have been identified that are consistently linked to increased risk of MM, MGUS or the transition between the two.

The overall goal is to identify risk genes for dysglobulinemia, and more specifically Multiple Myeloma. This will involve the conservation of cells in a bank and genetic sequencing on samples obtained from families with at least two cases of dysglobulinemia. Material used for sequencing is likely to include fresh peripheral blood cells or lymphoblastoid lines established from peripheral blood lymphocytes of patients.

Condition or disease Intervention/treatment Phase
Dysglobulinemia Genetic: Genetic analysis of peripheral blood samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Identification of Genetic Factors Predisposing to Dysglobulinemia
Actual Study Start Date : February 6, 2008
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Identification of genetic factors in dysglobulinemia cases Genetic: Genetic analysis of peripheral blood samples
M.D investigators report the identified families with all the information: description of the familial area (for example: 2 cases father and son), last medical report for the case with the type of dysglobulinemia, monoclonal component isotype, medical background and contact information for one of the patients or cases with Name/surname/Date of Birth/address and phone. They contact the patient to explain the study and establish the family pedigree. They collect the information on all the family members and send to the patient a mail: an information note on the study, a prescription for the blood sample and the informed consents. They proceed in the same way for the relatives with the additional prescription: EIP. They organize the logistic in the medical lab or hospital chosen by the person. They receive 4 Heparin and 1 serum tubes for each and with this, they obtain a large amount of biological material for the genetic analysis thanks to the establishment of lymphoblastoid cell lines

Primary Outcome Measures :
  1. Data of a bank cells, clinically annotated, from families with at least 2 cases of dysglobulinemia and at least 1 case alive.plasma cell dysplasia [ Time Frame: up to 48 months ]

    The investigator collects blood samples from patients with dysglobulinemia and their relatives and with this, the investigators constitutes the bank cells thanks to the establishment of lymphoblastoid cell lines.

    The investigator considers as "dysglobulinemia" cases patients with Multiple Myeloma, MGUS, Waldenström's disease and MGUS (monoclonal gammopathy of unknown significance ) as wells as plasmacytomas confirmed histologically or cytologically.

Secondary Outcome Measures :
  1. Single Nucleotide Polymorphism array for identification of polymorphisms predictive of dysglobulinemia [ Time Frame: at day 0 ]
    The biological material, obtained from fresh peripheral blood cells and from Lymphoblastoid cells lines, is used for pangenic sequencing. It allows to better understand the mechanism of genetic variations who could be involve in the myeloma genesis

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:   Yes

Inclusion Criteria:

  • 2 cases per family at least
  • 1 case alive at least
  • biological material available for 1 case at least
  • Patients give their informed consent
  • attached to the French Health protection service

Exclusion Criteria:

  • Age under 18

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): NCT02853214

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Contact: Charles DUMONTET, MD
Contact: Delphine DEMANGEL

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Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Charles DUMONTET Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon Identifier: NCT02853214    
Other Study ID Numbers: 2007-460
2007-A00644-49 ( Other Identifier: ID-RCB )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Multiple Myeloma
genetic factors