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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