Multiple Myeloma (MM)NCT07684274
Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics
An observational study of Multiple Myeloma (MM) and Smoldering Multiple Myeloma (SMM), run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma (MM), Smoldering Multiple Myeloma (SMM), MGUS
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2026to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age over 40 years.
- Diagnosed with MM, SMM, or MGUS through standard diagnostic procedures.
- Voluntarily participating and signed written informed consent.
Who cannot join
- 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.
About this study
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.
- Medical subject headings
- Multiple Myeloma, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start13 Jun 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc.
- Responsible party
- Principal investigator, Lei Fan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684274
- Sponsor's protocol ID
- 2026-SR-462
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No