ctDNA Methylation Sequencing for Myeloma

Multiple Myeloma Clinical Trial

Official title:

Circulating Tumor DNA Methylation Sequencing for Multiple Myeloma Minimal Residual Disease Detection and Clonal Evolution Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578625
• Other study ID #: ctDNA-MM-2022
• Status: Recruiting
• Start date: August 31, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2022
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Gang An, PhD
• Phone: +86 18649031258
• Email: angang[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. To carry out research on minimal residual disease (MRD) monitoring in patients with multiple myeloma (MM) based on plasma circulating tumor DNA (ctDNA) methylation sequencing, which aims to explore new MRD detection methods for MM; 2. Carry out ctDNA-based methylation sequencing in newly diagnosed, remission, and, relapsed MM patients, to track the clonal evolution patterns; and explore the in the initial diagnosis-remission-relapse stage of MM, track the clonal evolution characteristics of methylation profiles in MM patients during the disease progression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 30, 2025
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• For myeloma patients: i) Age no less than 18 and no more than 75; ii) Diagnosed with symptomatic multiple myeloma according to IMWG consensus; iii) Provide informed consent in accordance with the declaration of Helsinki.
• For healthy controls: i) Age no less than 18 and no more than 75; ii) Provide informed consent in accordance with the declaration of Helsinki.

Exclusion Criteria:

• For myeloma patients: i) Insufficient amount of peripheral blood obtained; ii) Methylation sequencing failed due to technical reasons.
• For healthy controls: i) Insufficient amount of peripheral blood obtained; ii) Methylation sequencing failed due to technical reasons.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• plasma circulation DNA methylation sequencing
10 mL of peripheral blood will be drawn from 60 multiple myeloma patients at diagnosis, 4 months post-induction, and at relapse, and cell-free DNA is then extracted and undergo bisulfite methylation sequencing.

Locations

Country	Name	City	State
China	Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital	MethylGene Tech Co., Ltd. China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sample Collection Completed	When the peripheral blood samples required for the study have been collected	From Aug 31 2022 to Jun 30 2025