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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics
- ClinicalTrials.gov ID
- NCT07684274
- Acronym / sponsor ID
- 2026-SR-462
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc.
- Study start
- 13 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Age over 40 years.
- Diagnosed with MM, SMM, or MGUS through standard diagnostic procedures.
- Voluntarily participating and signed written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and Specificity
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Related trials for Multiple Myeloma (MM)
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
RecruitingPhase 3
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
High Risk Smoldering Multiple Myeloma (HR-SMM)
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
Not yet recruitingPhase 1
Engineered Dendritic Cell Vaccines for Multiple Myeloma
Multiple Myeloma or Plasmacytoma
RecruitingPhase 1
ELEVATE-MM: Elotuzumab, Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Myeloma, Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma (MM) and Smoldering Multiple Myeloma (SMM), run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.