An observational study in Multiple Myeloma (MM), Smoldering Multiple Myeloma (SMM) and MGUS, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 290 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
Time frame: Baseline
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University