Familial Dysglobulinemia

NCT ID: NCT02853214

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1868 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-06

Study Completion Date

2023-09-25

Brief Summary

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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

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Conditions

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Dysglobulinemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Identification of genetic factors in dysglobulinemia cases

Group Type EXPERIMENTAL

Genetic analysis of peripheral blood samples

Intervention Type GENETIC

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

Interventions

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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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles DUMONTET

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Service d'Oncologie-Radiothérapie - CHU Pointe-à-Pitre/Abymes Guadeloupe

Pointe à Pitre, Guadeloupe, France

Site Status

Service de Médecine Interne-Hématologie, CHU de Fort de France Fort de France

Fort-de-France, Martinique, France

Site Status

CHU d'ABBEVILLE

Abbeville, , France

Site Status

CHU Amiens Picardie

Amiens, , France

Site Status

CHU Groupe Hospitalier Sud Hématologie Clinique

Amiens, , France

Site Status

CH d'Avignon

Avignon, , France

Site Status

CHU de Besançon

Besançon, , France

Site Status

CH de Blois Service d'Hématologie

Blois, , France

Site Status

Hôpital Avicenne Service d'Hématologie

Bobigny, , France

Site Status

Service d'Hématologie clinique et Thérapie Cellulaire, CHU de BORDEAUX

Bordeaux, , France

Site Status

CHU Morvan

Brest, , France

Site Status

Service d'hématologie Clinique

Caen, , France

Site Status

Hématolgie- Hôpital privé Cesson-Sévigné

Cesson-Sévigné, , France

Site Status

CH William Morey, Service d'Hémato-Oncologie

Chalon-sur-Saône, , France

Site Status

CHU de Chartres

Chartres, , France

Site Status

Département d'Oncogénitique - Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Hôpital Sud Francilien

Corbeil-Essonnes, , France

Site Status

Service d'Hématologie Clinique, CHU de Dijon

Dijon, , France

Site Status

Centre Hospitalier de Dunkerque

Dunkirk, , France

Site Status

GHM, Institut Daniel Hollard

Grenoble, , France

Site Status

CHU Albert Michallon

Grenoble, , France

Site Status

Service d'Hématologie, CHU de Versailles

Le Chesnay, , France

Site Status

Centre Jean Bernard Clinique Victor Hugo

Le Mans, , France

Site Status

Service d'Onco-hématologie, Hôpital Saint-Vincent GH-ICL

Lille, , France

Site Status

Service des Maladies du Sang CHU Lille

Lille, , France

Site Status

Département d'Oncogénétique, Centre Paoli Calmettes

Marseille, , France

Site Status

CHR-Metz-Thionville, Hôpital de Mercy, Service d'Hématologie

Metz, , France

Site Status

CHU d'Annecy

Metz-Tessy, , France

Site Status

Hôpital Saint-Eloi, Département d'Hématologie clinique

Montpellier, , France

Site Status

Service d'Oncologie Médical, Centre Azuréen de Canrérologie-1

Mougins, , France

Site Status

CHU-HÔTEL -Dieu de Nantes

Nantes, , France

Site Status

Hôpital de l'Archet 1

Nice, , France

Site Status

CHU Carémeau

Nîmes, , France

Site Status

Institut Curie

Paris, , France

Site Status

Hôpital St Antoine Service des maladies du Sang

Paris, , France

Site Status

Jean Paul FermandService Immuno-Hématologie Hôpital Saint Louis

Paris, , France

Site Status

Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

Hôpital Robert Debré Service du Professeur A. DELMER Hématologie Clinique

Reims, , France

Site Status

CHU de Rennes Hôpital Sud

Rennes, , France

Site Status

CH de Rodez

Rodez, , France

Site Status

Hôpital de Saint- Germain en Laye

Saint-Germain-en-Laye, , France

Site Status

Département d'Hématologie à l'Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Site Status

Hôpital Purpan Service d'Hématologie

Toulouse, , France

Site Status

Centre Hospitalier de Valence

Valence, , France

Site Status

CHU de Nancy, Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Hôpital Privé de Villeneuve d'Ascq

Villeneuve-d'Ascq, , France

Site Status

Countries

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France

References

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Dumontet C, Demangel D, Galia P, Karlin L, Roche L, Fauvernier M, Golfier C, Laude MC, Leleu X, Rodon P, Roussel M, Azais I, Doyen C, Slama B, Manier S, Decaux O, Pertesi M, Beaumont M, Caillot D, Boyle EM, Cliquennois M, Cony-Makhoul P, Doncker AV, Dorvaux V, Petillon MO, Fontan J, Hivert B, Leduc I, Leyronnas C, Macro M, Maigre M, Mariette C, Mineur P, Rigaudeau S, Royer B, Vincent L, Mckay J, Perrial E, Garderet L. Clinical characteristics and outcome of 318 families with familial monoclonal gammopathy: A multicenter Intergroupe Francophone du Myelome study. Am J Hematol. 2023 Feb;98(2):264-271. doi: 10.1002/ajh.26785. Epub 2023 Jan 1.

Reference Type BACKGROUND
PMID: 36588407 (View on PubMed)

Other Identifiers

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2007-A00644-49

Identifier Type: OTHER

Identifier Source: secondary_id

2007-460

Identifier Type: -

Identifier Source: org_study_id

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