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

NCT ID: NCT05536700

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm, Residual

Conditions: Keywords:
mass spectrometry
serum immunoglobulin
minimal residual disease
MRD
EasyM
M protein

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Retrospective

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.

Criteria for eligibility:

Study pop:
Subjects diagnosed with MM.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: Subjects with available baseline and sequential serum samples. Exclusion Criteria: Subjects without baseline and sequential serum samples.

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: InsituteHBDH

Address:
City: Tianjin
Zip: 300000
Country: China

Status: Recruiting

Contact:
Last name: Gang An, PhD&MD

Phone: 008613502181109
Email: angang@ihcams.ac.cn

Start date: December 31, 2021

Completion date: December 31, 2022

Lead sponsor:
Agency: Institute of Hematology & Blood Diseases Hospital, China
Agency class: Other

Collaborator:
Agency: Shanghai Kuaixu Biotechnology Co., Ltd
Agency class: Other

Source: Institute of Hematology & Blood Diseases Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05536700

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