Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics

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.

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Key information

Conditions

Multiple Myeloma (MM) Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders MGUS Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Precancerous Conditions Smoldering Multiple Myeloma Smoldering Multiple Myeloma (SMM) Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

Nanjing Geneseeq Technology Inc.

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 6, 2026
Registry last updated: Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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