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| Name | Class |
|---|---|
| Nanjing Geneseeq Technology Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011230 | Precancerous Conditions |
| D006942 | Hypergammaglobulinemia |