Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

have myelodysplastic syndrome, or multiple myeloma, or monoclonal gammopathy of undetermined significance, or Schnitzler's syndrome.

have a fever of undetermined etiology associated with one of the following symptoms: rash, arthralgia or arthritis, serositis, abdominal pain.

Disqualifiers

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.

Trial population

Inpatients and out wil be recruited in tertiary university centre of the Assitance Publique des Hopitaux de Paris.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 2 trial groups
Group A: Patient with Monoclonal gammopathies of inflammatory significance
Group B: Control group

Trial outcomes

Primary outcomes

1

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.

Time frame
At inclusion

Secondary outcomes

1

Cytokine profile measurement, with ELISA or quantitative PCR.

Measurment of main inflammatory cytokine using ELISA, PCR and flow-cytometry. This measurement will be done on leukocytes and plasma from patients.

Time frame
At inclusion

Other outcomes

Sponsors and contacts

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