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Familial Dysglobulinemia (PreFamDys)

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

Tracking Information
First Submitted Date  ICMJE July 13, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE February 6, 2008
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Familial Dysglobulinemia
Official Title  ICMJE Identification of Genetic Factors Predisposing to Dysglobulinemia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Dysglobulinemia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Identification of genetic factors in dysglobulinemia cases
Intervention: Genetic: Genetic analysis of peripheral blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Charles DUMONTET, MD charles.dumontet@chu-lyon.fr
Contact: Delphine DEMANGEL delphine.demangel@univ-lyon1.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02853214
Other Study ID Numbers  ICMJE 2007-460
2007-A00644-49 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charles DUMONTET Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP