Rationale for Cytogenetic Risk Stratification by Imaging Flow Cytometry in Multiple Myeloma

NCT03983486 | Withdrawn

• 1 other identifier: PI2018_843_0002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multiple Myeloma

Keywords

IS-FISH; Imaging flow cytometry; Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Detection of plasmocytes by imaging flow cytometry techniques in plasmocytes cell line.

  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).

  during the first six months of the study

• Detection of plasmocytes by imaging flow cytometry techniques in multiple myeloma bone marrow (MM BM).

  Cells from BM (bone marrow) aspiration will be processed and analyzed on the ISX (Image Stream X technology) in Amiens.

  from 6 months after the beginning of the study to two years after the beginning of the study

Interventions

Imaging flow cytometry in multiple myeloma OTHER

Combination of immunophenotyping by flow cytometry and FISH in suspension (IS-FISH) may provide both cytogenetic and phenotypic information for a large number of cells in a single test. In this scope, a recent study demonstrated a proof of concept for IS-FISH to detect non pathological signals with the new ImageStream X technology (ISX).1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with multiple myeloma (MM)

You may qualify if:

• 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

You may not qualify if:

• \<5% plasma cells in BM.
• Pre-bone marrow autograft samples

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: June 12, 2019
• Study Start: November 30, 2018
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)