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Rationale for Cytogenetic Risk Stratification by Imaging Flow Cytometry in Multiple Myeloma (CIF-PM)

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ClinicalTrials.gov Identifier: NCT03983486
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment
Multiple Myeloma Other: Imaging flow cytometry in multiple myeloma

Detailed 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. In a second time, the protocol will be applied to MM BM. Cells from BM aspiration will be processed and analysed on the ISX in Amiens. Based on last years local activity, this step is expected to last 2 years, so as to be able to obtain 5 samples from patients harbouring of each prototypical cytogenetic aberration above described. Inclusions will be guided by the results of PCS conducted before the first treatment initiation. Finally the results will be compared with PCS.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: 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)
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Imaging flow cytometry in multiple myeloma
    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


Primary Outcome Measures :
  1. Detection of plasmocytes by imaging flow cytometry techniques in plasmocytes cell line. [ Time Frame: during the first six months of the study ]

    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).

  2. Detection of plasmocytes by imaging flow cytometry techniques in multiple myeloma bone marrow (MM BM). [ Time Frame: from 6 months after the beginning of the study to two years after the beginning of the study ]
    Cells from BM (bone marrow) aspiration will be processed and analyzed on the ISX (Image Stream X technology) in Amiens.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with multiple myeloma (MM)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983486


Contacts
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Contact: YANN FERRET 03-22-08-70-23 ferret.yann@chu-amiens.fr

Locations
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France
CHU Amiens-Picardie Recruiting
Amiens, France, 80054
Contact: Yann FERRET    03-22-08-70-23    ferret.yann@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03983486     History of Changes
Other Study ID Numbers: PI2018_0043_002
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
IS-FISH
Imaging flow cytometry
Multiple Myeloma
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Multiple Myeloma
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases