Clinical trial · Observational
Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics
NCT07684274CI-TRIAL-00116931not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MGUS | Monoclonal Gammopathy of Undetermined Significance | ALIAS | 0.90 |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
| Smoldering Multiple Myeloma (SMM) | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Training Set
- description
- 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.
- label
- Validation Set
- description
- 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.
Primary outcomes (1)
- measure
- Sensitivity and Specificity
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.