Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics

July 1, 2026 updated by: Lei Fan, The First Affiliated Hospital with Nanjing Medical University
Study on Early Screening of Myeloma Based on Liquid Biopsy cfDNA Fragmentomics Technology. This study aims to construct and validate a set of machine learning models for the early screening of myeloma tailored to the Chinese population, based on plasma cfDNA fragmentomics features, to effectively distinguish myeloma patients from healthy individuals.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

290

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Study Population Description Target Population: Chinese adults aged 40 years, including patients with plasma cell dyscrasias and healthy controls.

Patient Group: Individuals with a laboratory- and clinically-confirmed diagnosis of MM, SMM, or MGUS following standard diagnostic guidelines.

Healthy Controls: Age-matched healthy individuals with no active malignancies or major systemic diseases.

General Eligibility Summary: All participants must voluntarily sign a written informed consent form. Individuals with recent blood transfusions (within 7 days), prior histories of other cancers or systemic oncology therapies within 5 years, or histories of organ/allogeneic transplants will be excluded, alongside any candidates deemed ineligible by the investigator.

Description

Inclusion Criteria:

  • Age over 40 years.
  • Diagnosed with MM, SMM, or MGUS through standard diagnostic procedures.
  • Voluntarily participating and signed written informed consent.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Prior cancer diagnosis within the past 5 years, or history of any form of systemic cancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.).
  • History of organ transplantation, or allogeneic bone marrow or stem cell transplantation.
  • History of blood transfusion within 7 days prior to blood collection.
  • Poor compliance or potential interference with signing informed consent as judged by the investigator, or any other conditions rendering the subject unsuitable for the study.

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

Cohorts and Interventions

Group / Cohort
Training Set
A cohort of ≥100 MM patients, 70 MGUS/SMM patients (mixed at a 1:1 ratio), and 30 healthy controls will be used to train and construct the myeloma early screening model.
Validation Set
A cohort of 30 MM patients, 30 MGUS/SMM patients (mixed at a 1:1 ratio), and 30 healthy controls will be used to validate the performance of the myeloma early screening model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: Baseline
The early screening model will be developed using the training set; its sensitivity and specificity will then be evaluated in the validation set based on the consistency between the model's classification and clinical diagnosis.
Baseline

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Nanjing Geneseeq Technology Inc.

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 (Estimated)

June 13, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-SR-462

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.

Clinical Trials on MGUS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe