Clinical trial NCT02853214: Familial Dysglobulinemia
Official title: Identification of Genetic Factors Predisposing to Dysglobulinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysglobulinemia
Keywords: Dysglobulinemia
Multiple Myeloma
MGUS
Waldenström
genetic factors
Sequencing
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 1868
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: up to 48 months
Secondary outcomes:
measure: Single Nucleotide Polymorphism array for identification of polymorphisms predictive of dysglobulinemia
timeFrame: at day 0
Other outcomes:
Locations:
city: POINTE-à-PITRE
country: France
facility: Service d'Oncologie-Radiothérapie - CHU Pointe-à-Pitre/Abymes Guadeloupe
state: Guadeloupe
city: Fort-de-France
country: France
facility: Service de Médecine Interne-Hématologie, CHU de Fort de France Fort de France
state: Martinique
city: Abbeville
country: France
facility: CHU d'ABBEVILLE
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Amiens
country: France
facility: CHU Groupe Hospitalier Sud Hématologie Clinique
city: Avignon
country: France
facility: CH d'Avignon
city: Besançon
country: France
facility: CHU de Besançon
city: Blois
country: France
facility: CH de Blois Service d'Hématologie
city: Bobigny
country: France
facility: Hôpital Avicenne Service d'Hématologie
city: Bordeaux
country: France
facility: Service d'Hématologie clinique et Thérapie Cellulaire, CHU de BORDEAUX
city: Brest
country: France
facility: CHU Morvan
city: Caen
country: France
facility: Service d'hématologie Clinique
city: Cesson-Sévigné
country: France
facility: Hématolgie- Hôpital privé Cesson-Sévigné
city: Chalon-sur-Saône
country: France
facility: CH William Morey, Service d'Hémato-Oncologie
city: Chartres
country: France
facility: CHU de Chartres
city: Clermont-Ferrand
country: France
facility: Département d'Oncogénitique - Centre Jean Perrin
city: Corbeil-Essonnes
country: France
facility: Hôpital Sud Francilien
city: Dijon
country: France
facility: Service d'Hématologie Clinique, CHU de Dijon
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Grenoble
country: France
facility: GHM, Institut Daniel Hollard
city: Grenoble
country: France
facility: CHU Albert Michallon
city: Le Chesnay
country: France
facility: Service d'Hématologie, CHU de Versailles
city: Le Mans
country: France
facility: Centre Jean Bernard Clinique Victor Hugo
city: Lille
country: France
facility: Service d'Onco-hématologie, Hôpital Saint-Vincent GH-ICL
city: Lille
country: France
facility: Service des Maladies du Sang CHU Lille
city: Marseille
country: France
facility: Département d'Oncogénétique, Centre Paoli Calmettes
city: Metz-Tessy
country: France
facility: CHU d'Annecy
city: Metz
country: France
facility: CHR-Metz-Thionville, Hôpital de Mercy, Service d'Hématologie
city: Montpellier
country: France
facility: Hôpital Saint-Eloi, Département d'Hématologie clinique
city: Mougins
country: France
facility: Service d'Oncologie Médical, Centre Azuréen de Canrérologie-1
city: Nantes
country: France
facility: CHU-HÔTEL -Dieu de Nantes
city: Nice
country: France
facility: Hôpital de l'Archet 1
city: Nîmes
country: France
facility: CHU Carémeau
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital St Antoine Service des maladies du Sang
city: Paris
country: France
facility: Jean Paul FermandService Immuno-Hématologie Hôpital Saint Louis
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: Hôpital Robert Debré Service du Professeur A. DELMER Hématologie Clinique
city: Rennes
country: France
facility: CHU de Rennes Hôpital Sud
city: Rodez
country: France
facility: CH de Rodez
city: Saint-Germain-en-Laye
country: France
facility: Hôpital de Saint- Germain en Laye
city: Saint-Priest-en-Jarez
country: France
facility: Département d'Hématologie à l'Institut de Cancérologie de la Loire
city: Toulouse
country: France
facility: Hôpital Purpan Service d'Hématologie
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy, Hôpital de Brabois
city: Villeneuve d'Ascq
country: France
facility: Hôpital Privé de Villeneuve d'Ascq
Study officials:
affiliation: Hospices Civils de Lyon
name: Charles DUMONTET
role: PRINCIPAL_INVESTIGATOR
References: