Monitoring minimal residual disease in multiple myeloma using ctDNA methylation sequencing
Circulating Tumor DNA Methylation Sequencing for Multiple Myeloma Minimal Residual Disease Detection and Clonal Evolution Monitoring
This study is testing a new way to track leftover cancer cells in people with multiple myeloma by looking at changes in their blood samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05578625 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on monitoring minimal residual disease (MRD) in patients with multiple myeloma through the analysis of circulating tumor DNA (ctDNA) methylation sequencing. It aims to explore new methods for MRD detection by tracking clonal evolution patterns in patients at various stages of the disease, including newly diagnosed, in remission, and relapsed cases. The study will involve collecting plasma samples from participants to analyze their methylation profiles and understand disease progression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 diagnosed with symptomatic multiple myeloma.
Not a fit: Patients with insufficient blood samples or those whose methylation sequencing fails due to technical reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of multiple myeloma, enhancing patient outcomes.
How similar studies have performed: While there is ongoing research in ctDNA monitoring, this specific approach using methylation sequencing for multiple myeloma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: InsituteHBDH — Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020
- Study coordinator: Gang An, PhD
- Email: angang@ihcams.ac.cn
- Phone: +86 18649031258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.