Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT06302699
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-05-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Subjects diagnosed with MM.
• With available baseline and sequential next-generation flow-MRD data.

Exclusion Criteria

• Subjects without baseline and sequential next-generation flow-MRD data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of copy number variation	From May 1, 2023 to December 31, 2023

Secondary Outcome Measures

Name	Time	Method
Serial monitoring of treatment response	From January 1, 2024 to May 31, 20224