Clinical trial · Observational
Rationale for Cytogenetic Risk Stratification by Imaging Flow Cytometry in Multiple Myeloma
Use of Imaging Flow Cytometry for Immunophenotyping Coupled With Cytogenetic Abnormalities Detection by Fluorescent in Situ Hybridization (FISH) and Applicability in Cytogenetic Risk Stratification of Multiple Myeloma (CIF-PM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): technical problem
Summary
Brief summary (as posted)
A pioneer study demonstrated a proof of concept for IS-FISH with the new ISX technology. This state of the art technology has been recently acquired by the CHU of Amiens. In the present study the investigators want to establish a workflow for simultaneous immunostaining and characterization of FISH cytogenetic pathological signals with the imaging flow cytometer ISX, such as chromosomic gains, losses and translocations in multiple myeloma (MM). The gold standard technology for the detection of prognostic cytogenetic aberrations in MM is a FISH analysis after bone marrow (BM) plasma cells sorting (PCS).2,3 In MM, plasma cells isolation is usually based on CD38 and/or CD138 expression. Cytogenetic risk stratification is guided by the detection of 4 chromosomal aberrations: TP53 and CDKN2C deletions, CKS1B gains and t(4;14) translocation. Thanks to ISX technology the investigators may avoid cumbersome task of cell sorting (outsourced service for our hospital) meanwhile measuring precisely and qualitatively aberrant FISH signals on a large amount of cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging flow cytometry in multiple myeloma | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Detection of plasmocytes by imaging flow cytometry techniques in plasmocytes cell line.
- timeFrame
- during the first six months of the study
- description
- In a first time (period of 6 months), the development will be performed on CD38 and/or CD138 expressing cell lines. Regular FISH protocols will be finely tuned to fit immunophenotyping and cells in suspension constraints needed in IS-FISH (FISH in suspension). Development of the technique of the first period will be made in order to test : * the ability to measure FISH and immunostaining signals simultaneously * the ability to count a number of FISH spots consistent with ploidy (eg 1 X centromeric signal for men, 2 for women).
- measure
- Detection of plasmocytes by imaging flow cytometry techniques in multiple myeloma bone marrow (MM BM).
- timeFrame
- from 6 months after the beginning of the study to two years after the beginning of the study
- description
- Cells from BM (bone marrow) aspiration will be processed and analyzed on the ISX (Image Stream X technology) in Amiens.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Available BM samples from active MM patients followed in the CHU of Amiens will be selected on the basis of PCS analysis systematically performed before treatment initiation. * signed consent Exclusion Criteria: * \<5% plasma cells in BM. * Pre-bone marrow autograft samples
References
Publications (0)
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