Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics

NCT07684274 | Not Yet Recruiting

• 1 other identifier: 2026-SR-462
• Study Type: observational
• Target: 290
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Myeloma (MM); Smoldering Multiple Myeloma (SMM); MGUS

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Nanjing Geneseeq Technology Inc.: collaborator

MeSH Terms

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma

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; Precancerous Conditions; Hypergammaglobulinemia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor, Ph.D. Supervisor, Director of the Department of Hematology

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: July 6, 2026
• Study Start: June 13, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07