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

Clinical Utility of Ultrasensitive Chromosomal Aberrations Detection (UCAD) for Detecting Minimal Residual Disease (MRD) and Monitoring Clonal Evolution by Low-Pass Whole Genome Sequencing in Multiple Myeloma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06302699

Enrollment

Registered

2024-03-12

Start date

2023-05-01

Completion date

2026-03-01

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Minimal Residual Disease, Low-Pass Whole Genome Sequencing, Clonal Evolution, Ultrasensitive Chromosomal Aberrations Detection

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Detection of copy number variation	From May 1, 2023 to December 31, 2023

Secondary

Measure	Time frame
Serial monitoring of treatment response	From January 1, 2024 to May 31, 20224

Countries

China

Contacts

Primary ContactGang An, PhD&amp;MD

angang@ihcams.ac.cn008613502181109

Backup ContactJian Cui, MBBS

cuijian@ihcams.ac.cn008617711354648

Outcome results