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Trial Title:
ctDNA Methylation Sequencing for Myeloma
NCT ID:
NCT05578625
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
circulationg tumor DNA
methylation sequencing
minimal residual disease
clonal evolution
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
plasma circulation DNA methylation sequencing
Description:
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.
Arm group label:
Myeloma
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.
Criteria for eligibility:
Study pop:
For patients aged between 18 and 75, and diagnosed with symptomatic multiple myeloma
according to IMWG consensus will be included in this study.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Gang An, PhD&MD
Phone:
008613502181109
Email:
angang@ihcams.ac.cn
Start date:
August 31, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Collaborator:
Agency:
MethylGene Tech Co., Ltd. China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05578625
