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出境医 / 临床实验 / Rationale for Cytogenetic Risk Stratification by Imaging Flow Cytometry in Multiple Myeloma (CIF-PM)

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

Study Description
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.
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 0 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
Actual Primary Completion Date : February 10, 2020
Actual Study Completion Date : February 10, 2020
Arms and Interventions
Outcome Measures
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.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 13, 2018
First Posted Date June 12, 2019
Last Update Posted Date July 17, 2020
Actual Study Start Date November 30, 2018
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2019)
  • 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).
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rationale for Cytogenetic Risk Stratification by Imaging Flow Cytometry in Multiple Myeloma
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)
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with multiple myeloma (MM)
Condition Multiple Myeloma
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: July 15, 2020) 		0
Original Estimated Enrollment
 (submitted: June 11, 2019) 		20
Actual Study Completion Date February 10, 2020
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03983486
Other Study ID Numbers PI2018_843_0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date July 2020

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