Dysglobulinemia Clinical Trial
— PreFamDysOfficial title:
Identification of Genetic Factors Predisposing to Dysglobulinemia
| Verified date | February 2023 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1868 |
| Est. completion date | September 25, 2023 |
| Est. primary completion date | September 25, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU d'ABBEVILLE | Abbeville | |
| France | CHU Amiens Picardie | Amiens | |
| France | CHU Groupe Hospitalier Sud Hématologie Clinique | Amiens | |
| France | CH d'Avignon | Avignon | |
| France | CHU de Besançon | Besançon | |
| France | CH de Blois Service d'Hématologie | Blois | |
| France | Hôpital Avicenne Service d'Hématologie | Bobigny | |
| France | Service d'Hématologie clinique et Thérapie Cellulaire, CHU de BORDEAUX | Bordeaux | |
| France | CHU Morvan | Brest | |
| France | Service d'hématologie Clinique | Caen | |
| France | Hématolgie- Hôpital privé Cesson-Sévigné | Cesson-Sévigné | |
| France | CH William Morey, Service d'Hémato-Oncologie | Chalon-sur-Saône | |
| France | CHU de Chartres | Chartres | |
| France | Département d'Oncogénitique - Centre Jean Perrin | Clermont-Ferrand | |
| France | Hôpital Sud Francilien | Corbeil-Essonnes | |
| France | Service d'Hématologie Clinique, CHU de Dijon | Dijon | |
| France | Centre Hospitalier de Dunkerque | Dunkerque | |
| France | Service de Médecine Interne-Hématologie, CHU de Fort de France Fort de France | Fort-de-France | Martinique |
| France | CHU Albert Michallon | Grenoble | |
| France | GHM, Institut Daniel Hollard | Grenoble | |
| France | Service d'Hématologie, CHU de Versailles | Le Chesnay | |
| France | Centre Jean Bernard Clinique Victor Hugo | Le Mans | |
| France | Service d'Onco-hématologie, Hôpital Saint-Vincent GH-ICL | Lille | |
| France | Service des Maladies du Sang CHU Lille | Lille | |
| France | Département d'Oncogénétique, Centre Paoli Calmettes | Marseille | |
| France | CHR-Metz-Thionville, Hôpital de Mercy, Service d'Hématologie | Metz | |
| France | CHU d'Annecy | Metz-Tessy | |
| France | Hôpital Saint-Eloi, Département d'Hématologie clinique | Montpellier | |
| France | Service d'Oncologie Médical, Centre Azuréen de Canrérologie-1 | Mougins | |
| France | CHU-HÔTEL -Dieu de Nantes | Nantes | |
| France | Hôpital de l'Archet 1 | Nice | |
| France | CHU Carémeau | Nîmes | |
| France | Hôpital St Antoine Service des maladies du Sang | Paris | |
| France | Institut Curie | Paris | |
| France | Jean Paul FermandService Immuno-Hématologie Hôpital Saint Louis | Paris | |
| France | Hospices Civils de Lyon | Pierre Benite | |
| France | Service d'Oncologie-Radiothérapie - CHU Pointe-à-Pitre/Abymes Guadeloupe | POINTE-à-PITRE | Guadeloupe |
| France | CHU de Poitiers | Poitiers | |
| France | Hôpital Robert Debré Service du Professeur A. DELMER Hématologie Clinique | Reims | |
| France | CHU de Rennes Hôpital Sud | Rennes | |
| France | CH de Rodez | Rodez | |
| France | Hôpital de Saint- Germain en Laye | Saint-Germain-en-Laye | |
| France | Département d'Hématologie à l'Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | |
| France | Hôpital Purpan Service d'Hématologie | Toulouse | |
| France | Centre Hospitalier de Valence | Valence | |
| France | CHU de Nancy, Hôpital de Brabois | Vandœuvre-lès-Nancy | |
| France | Hôpital Privé de Villeneuve d'Ascq | Villeneuve d'Ascq |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. |
up to 48 months | |
| Secondary | Single Nucleotide Polymorphism array for identification of polymorphisms predictive of dysglobulinemia | 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 | at day 0 |