NCT04702932|Not Yet RecruitingDMC
Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies
GEN-HEMO-INF
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GEN-HEMO-INF
Sponsor study identifier
observational
30
1 country
1
Study Start
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Patients with monoclonal gammopathies either benign or malignant may develop inflammatory symptoms such as Schnitzler syndrome. We proposed to name those cases as monoclonal gammopathy of inflammatory significance, or MGIS. The aim of the study is to search for inflammatory pathway that may be activated in case MGIS and to search if the genetic of tumoral cell could explain those activations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2020
Actual (reported)January 11, 2021
Actual (reported)September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Whole exome sequencing of tumoral cells
We will perform a genetic study of tumoral cells using whole exome sequencing, We will use high throughput genetic sequencing technics, with help of a Nova seq 6000. We will use patients tumoral cells to do it.
At inclusion
Cytokine profile measurement, with ELISA or quantitative PCR.
At inclusion
This group of patient will present a monoclonal gammopathy associated with inflammatory symptoms without known origin.
The Control group will be healthy subject and patients with monoclonal gammopathies without inflammatory symptoms.
Inpatients and out wil be recruited in tertiary university centre of the Assitance Publique des Hopitaux de Paris.
Service de Médecine Interne
Paris, 75020, France
Blood samples
Sophie GEORGIN-LAVIALLE, PU-PH
Assistance Publique - Hôpitaux de Paris
First Submitted
November 19, 2020
First Posted
January 11, 2021
Study Start
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2026
Estimated (date passed)Prospective Evaluation of the Prognostic Impact of Measurable Residual Disease (MRD) Within a Phase III Study Comparing a Fixed Duration Therapy Versus Continuous Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma Requiring a First Salvage Treatment.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 11, 2021
Record last verified: 2020-12
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