Clinical trial · Observational
Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies
NCT04702932CI-TRIAL-00049348GEN-HEMO-INFnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Monoclonal Gammopathy of Undetermined Significance | Monoclonal Gammopathy of Undetermined Significance | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Waldenstrom Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patient with Monoclonal gammopathies of inflammatory significance
- description
- This group of patient will present a monoclonal gammopathy associated with inflammatory symptoms without known origin.
- label
- Control group
- description
- The Control group will be healthy subject and patients with monoclonal gammopathies without inflammatory symptoms.
Primary outcomes (1)
- measure
- Whole exome sequencing of tumoral cells
- timeFrame
- At inclusion
- description
- 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.
Secondary outcomes (1)
- measure
- Cytokine profile measurement, with ELISA or quantitative PCR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient over 18 years of age with the capacity to give express free and informed consent. * Patient followed in one of the services participating in the study and meeting the 2 following conditions 1. have myelodysplastic syndrome, or multiple myeloma, or monoclonal gammopathy of undetermined significance, or Schnitzler's syndrome. 2. have a fever of undetermined etiology associated with one of the following symptoms: rash, arthralgia or arthritis, serositis, abdominal pain. Exclusion Criteria: * Patient incapable of giving express free and informed consent. * Subject under guardianship, curatorship or safeguarding of justice. * Subject does not speak French. * Subject incapable of answering questions or expressing himself/herself. * Presence of a differential diagnosis that may explain the patient's symptoms.
References
Publications (0)
Data not yet available
No reference posted for this study.