Using Mass Spectrometry (EasyM) Detecting Minimal Residua... | NCT05536700

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

NCT05536700

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Status

Unknown status

Last Update Posted

Sep 13, 2022Actual

Enrollment

67Estimated

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2021Actual

Primary Completion Date

Sep 17, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Sep 8, 2022

First Submission Date that Met QC Criteria

Sep 8, 2022

First Posted Date

Sep 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2022

Last Update Posted Date

Sep 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

AnGang,MD, Professor, Institute of Hematology & Blood Diseases Hospital, ChinaPrincipal Investigator

Lead Sponsor

Institute of Hematology & Blood Diseases Hospital, ChinaOTHER

Collaborators

Name	Class
Shanghai Kuaixu Biotechnology Co., Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

67Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantitative measurement of M protein	Detecting the M protein concentration and its dynamic change curve	From June 6, 2022 to December 31, 2022

Secondary Outcomes

Measure	Description	Time Frame
sequence detection of M protein	Detecting the M protein sequence in each person	From December 31, 2021 to May 31, 2022

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with available baseline and sequential serum samples.

Exclusion Criteria:

Subjects without baseline and sequential serum samples.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects diagnosed with MM.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gang An	Contact	00861350218110		angang@ihcams.ac.cn
Gang An An	Contact	00861350218110		angang@ihcams.ac.cn

Overall Officials

Name	Affiliation	Role
InstituteHBDH	Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
InsituteHBDH	Recruiting	Tianjin		300000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38170583	Derived	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.

ID	Term
D009101	Multiple Myeloma
D018365	Neoplasm, Residual

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders