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NCT06302699 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06302699
Other study ID # UCAD-MM-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date March 1, 2026

Study information
Verified date March 2024
Source Institute of Hematology & Blood Diseases Hospital, China
Contact Gang An, PhD&MD
Phone 008613502181109
Email angang@ihcams.ac.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date March 1, 2026
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital, China

References & Publications (1)

Zeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of copy number variation From May 1, 2023 to December 31, 2023
Secondary Serial monitoring of treatment response From January 1, 2024 to May 31, 20224
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