ctDNA Methylation Sequencing for Myeloma

Sponsor
Institute of Hematology & Blood Diseases Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05578625
Collaborator
MethylGene Tech Co., Ltd. China (Other)
66
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34
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: plasma circulation DNA methylation sequencing

Study Design

Study Type:
Observational
Anticipated Enrollment :
66 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Circulating Tumor DNA Methylation Sequencing for Multiple Myeloma Minimal Residual Disease Detection and Clonal Evolution Monitoring
Actual Study Start Date :
Aug 31, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Myeloma

This study includes a total of 60 multiple myeloma patients, and peripheral blood will be collected at newly diagnosed, remission after 4 cycles of therapy, and, relapse stage.

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.

Outcome Measures

Primary Outcome Measures

  1. Sample Collection Completed [From Aug 31 2022 to Jun 30 2025]

    When the peripheral blood samples required for the study have been collected

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tianjin China 300020

Sponsors and Collaborators

  • Institute of Hematology & Blood Diseases Hospital
  • MethylGene Tech Co., Ltd. China

Investigators

  • Principal Investigator: InsituteHBDH, Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gang An, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT05578625
Other Study ID Numbers:
  • ctDNA-MM-2022
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gang An, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Institute of Hematology & Blood Diseases Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2022