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

January 11, 2023 updated by: Qiu Lugui

Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy arm
Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.
Diagnostic test: cfDNA 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
Cancer Arm
participants with newly diagnosed multiple myeloma, from whom blood samples will be collected.
Diagnostic test: cfDNA 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
Benign Arm
Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected.
Diagnostic test: cfDNA 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages.
Time Frame: 12 months
12 months
The performance of a cfDNA methylation-based prognostic model for multiple myeloma.
Time Frame: 12 months
Treatment response and survival outcomes, measured by ORR, CR, PFS, and OS, in high-risk group and low-risk group of multiple myeloma.
12 months
The specific cfDNA methylation landscape of multiple myeloma in China
Time Frame: 12 months
The differently methylated regions(DMRs) between multiple myeloma and healthy/benign controls.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qiu Lugui

Collaborators

Guangzhou Burning Rock Dx Co., Ltd.

Investigators

  • Principal Investigator: Lugui Qiu, MD, Ph.D, Chinese Academy of Medical Sciences & Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSCD2022004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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