CClinicalTrials.gg
Status unknownNCT05693012Updated Jan 20, 2023

Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma

An observational study in Multiple Myeloma, sponsored by Qiu Lugui. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-20.

Sponsored by Qiu Lugui · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
398
Ages
40 Years to 75 Years
Sex
All
01

Study summary

It is an observational, case-control study aimed at early-detection of multiple myeloma and constructing a prognostic model of multiple myeloma. The study will enroll approximately 398 participants including patients with multiple myeloma, patients with benign hematologic disorders and healthy participants.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • multiple myeloma
  • early detection
  • liquid biopsy
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 398 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Qiu Lugui is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Eligible participants will be recruited from the participating medical center and assigned into three arms, including participants with newly diagnosed multiple myeloma, benign hematologic disorders and healthy participants.

Eligibility criteria

Inclusion Criteria for Cancer Participants:

  • Age 40-75 years
  • Ability to provide a written informed consent
  • Pathologically confirmed diagnosis of multiple myeloma or highly suspicious cases of multiple myeloma
  • No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw

Inclusion Criteria for Benign Disease Participants:

  • Age 40-75 years
  • Ability to provide a written informed consent
  • Pathologically confirmed diagnosis of benign hematologic disorders or highly suspicious cases with benign hematologic disorders
  • No prior or ongoing radical treatment of the benign hematologic disorders prior to study blood draw

Inclusion Criteria for Healthy Participants

  • Age 40-75 years
  • Ability to provide a written informed consent
  • No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw

Exclusion Criteria for All Participants:

  • Insufficient qualified blood samples
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
  • Recipient of blood transfusion within 7 days prior to blood draw
  • Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen)

Additional Exclusion Criteria for Cancer Participants:

  • Other current malignant diseases or multiple primary tumors

Additional Exclusion Criteria for Benign Disease Participants:

  • Current or history of malignancies

Additional Exclusion Criteria for Healthy Participants:

  • Recipient of anti-infectious therapy within 14 days prior to study blood draw
  • Prior or ongoing treatment of cancer within 3 years prior to study blood draw
  • Current autoimmune disease or clinically significant or uncontrolled comorbidities
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
398 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cancer Arm

    participants with newly diagnosed multiple myeloma, from whom blood samples will be collected.

    Diagnostic Test: cfDNA methylation assessment

  • Benign Arm

    Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected.

    Diagnostic Test: cfDNA methylation assessment

  • Healthy arm

    Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.

    Diagnostic Test: cfDNA methylation assessment

Interventions

  • Diagnostic testcfDNA methylation assessment

    An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment

06

What researchers measure

Primary outcomes

  1. The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.

    Time frame: 12 months

Secondary outcomes

  1. The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages.

    Time frame: 12 months

  2. The performance of a cfDNA methylation-based prognostic model for multiple myeloma.

    Treatment response and survival outcomes, measured by ORR, CR, PFS, and OS, in high-risk group and low-risk group of multiple myeloma.

    Time frame: 12 months

  3. The specific cfDNA methylation landscape of multiple myeloma in China

    The differently methylated regions(DMRs) between multiple myeloma and healthy/benign controls.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
    Tianjin, Tianjin 300020, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05693012
Lead sponsor
Qiu Lugui
Collaborators
Guangzhou Burning Rock Dx Co., Ltd.
Responsible party
Qiu Lugui (Director of lymphoma & myeloma center, Institute of Hematology & Blood Diseases Hospital, China) — Sponsor-investigator
First posted
Jan 20, 2023
Start date
Aug 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jan 20, 2023

Study contacts

Lugui Qiu, MD, Ph.D
Contact
qiulg@ihcams.ac.cn
23909172
Mu Hao, Ph.D
Contact
haomu@ihcams.ac.cn
Lugui Qiu, MD, Ph.D
principal investigator · Chinese Academy of Medical Sciences & Peking Union Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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