ctDNA Methylation Sequencing for Myeloma

NCT05578625 | Unknown

• 1 other identifier: ctDNA-MM-2022
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Multiple Myeloma

Keywords

circulationg tumor DNA; methylation sequencing; minimal residual disease; clonal evolution

Outcome Measures

Primary Outcomes (1)

• Sample Collection Completed

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

  From Aug 31 2022 to Jun 30 2025

Study Arms (1)

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

Interventions

plasma circulation DNA methylation sequencing OTHER

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.

Myeloma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For patients aged between 18 and 75, and diagnosed with symptomatic multiple myeloma according to IMWG consensus will be included in this study.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

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

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, 300020, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• InsituteHBDH

  Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang An, PhD

CONTACT

+86 18649031258; angang@ihcams.ac.cn

Jian Cui, Bachelor

CONTACT

+86 177111354648; cuijian@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Science & Peking Union Medical College

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: October 13, 2022
• Study Start: August 31, 2022
• Primary Completion: August 31, 2023
• Study Completion: June 30, 2025
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)