Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics

N/ANot Yet RecruitingNCT07684274

The First Affiliated Hospital with Nanjing Medical University290 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

290

Conditions

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

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.