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

NCT ID: NCT05536700

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Subjects with available baseline and sequential serum samples.

Exclusion Criteria

Subjects without baseline and sequential serum samples.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Kuaixu Biotechnology Co., Ltd

UNKNOWN

Sponsor Role collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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AnGang,MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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InstituteHBDH

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020

Locations

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InsituteHBDH

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gang An

Role: CONTACT

00861350218110

Gang An An

Role: CONTACT

00861350218110

Facility Contacts

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Gang An, PhD&MD

Role: primary

008613502181109

References

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Fan H, Wang B, Shi L, Pan N, Yan W, Xu J, Gong L, Li L, Liu Y, Du C, Cui J, Zhu G, Deng S, Sui W, Xu Y, Yi S, Hao M, Zou D, Chen X, Qiu L, An G. Monitoring Minimal Residual Disease in Patients with Multiple Myeloma by Targeted Tracking Serum M-Protein Using Mass Spectrometry (EasyM). Clin Cancer Res. 2024 Mar 15;30(6):1131-1142. doi: 10.1158/1078-0432.CCR-23-2767.

Reference Type DERIVED
PMID: 38170583 (View on PubMed)

Other Identifiers

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EasyM-MM-2021

Identifier Type: -

Identifier Source: org_study_id

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