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Using Mass Spectrometry (EasyM) Detecting Minimal Residual Disease (MRD) in Multiple Myeloma

Sponsor
Institute of Hematology & Blood Diseases Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05536700
Collaborator
Shanghai Kuaixu Biotechnology Co., Ltd (Other)
67
Enrollment
1
Location
12
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while M-protein is a widely accepted biomarker used for multiple myeloma (MM) diagnose. Detecting MRD by monitoring M-protein using mass spectrometry (MS) is promising due to its high analytical sensitivity. To evaluate the correlation between MS-MRD and overall disease burden, over 60 patients with 500+ samples were identified for this study. The M-protein sequence and the patient-specific M-protein peptides of each patient were obtained by de novo protein sequencing platform using the diagnostic serum (> 30g/L). The follow- up samples were then measured by a parallel reaction monitoring (PRM) assay.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    67 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Utility of Mass Spectrometry (EasyM) for Detecting Minimal Residual Disease (MRD) by Monitoring Serum Monoclonal Immunoglobulins in Multiple Myeloma
    Actual Study Start Date :
    Dec 31, 2021
    Anticipated Primary Completion Date :
    Sep 17, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Quantitative measurement of M protein [From June 6, 2022 to December 31, 2022]

      Detecting the M protein concentration and its dynamic change curve

    Secondary Outcome Measures

    1. sequence detection of M protein [From December 31, 2021 to May 31, 2022]

      Detecting the M protein sequence in each person

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Subjects with available baseline and sequential serum samples.

    Exclusion Criteria:

    Subjects without baseline and sequential serum samples.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 InsituteHBDH Tianjin China 300000

    Sponsors and Collaborators

    • Institute of Hematology & Blood Diseases Hospital
    • Shanghai Kuaixu Biotechnology Co., Ltd

    Investigators

    • Principal Investigator: InstituteHBDH, Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AnGang,MD, Professor, Institute of Hematology & Blood Diseases Hospital
    ClinicalTrials.gov Identifier:
    NCT05536700
    Other Study ID Numbers:
    • EasyM-MM-2021
    First Posted:
    Sep 13, 2022
    Last Update Posted:
    Sep 13, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AnGang,MD, Professor, Institute of Hematology & Blood Diseases Hospital
    mass spectrometry
    serum immunoglobulin
    minimal residual disease
    MRD
    EasyM
    M protein
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Neoplasm, Residual

    Study Results

    No Results Posted as of Sep 13, 2022