Monoclonal GammopathiesNCT05686447
Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis
An observational study of Monoclonal Gammopathies and Multiple Myeloma, run by Zhujiang Hospital at 1 site in China.
Trial summary
To provide a comprehensive MALDI-TOF mass spectrometry method for detecting, characterizing, and quantifying M-protein, and to track M-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Monoclonal Gammopathies, Multiple Myeloma, M-protein
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Jul 2026
- How long will I take part?
- 2 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All the patients with Multiple myeloma hospitalized in Zhujiang hospital will be eligible to be enrolled. Also, their age- and sex- matched healthy controls making a physical examination in Zhujiang hospital will be eligible to be enrolled
Inclusion Criteria:(1) Inclusion criteria for cases: Serum samples from related people diagnosed with multiple myeloma were included in MALDI-TOF-MS analysis by serum protein electrophoresis (SPEP), serum immunofixation electrophoresis (IFE), Ig isotype detection and other methods. (2) Inclusion criteria of the controls were as follows: individuals in good health without obvious disease and with normal physical examination report; Avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex.
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Exclusion Criteria: samples with incomplete sample information and untraceable source; Samples whose sample volume is insufficient for testing; Samples that do not meet the requirements for sample collection and storage
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Hongwei Zhou, Professor, 18688489622, hzhou@smu.edu.cn
About this study
To provide a comprehensive MALDI-TOF mass spectrometry method for detecting, characterizing, and quantifying M-protein, and to track M-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment.
Read the detailed description
M-protein is a serum biomarker directly related to clonal plasma cell load in Multiple myeloma (MM) patients and can be used as a diagnostic marker to make out disease and a quantitative marker to track disease progression and response to treatment. Identification, typing and quantification of M-proteins are useful for initial diagnosis of disease, risk stratification and monitoring of response to treatment. Although the determination of M-protein can be used as an auxiliary diagnosis of multiple myeloma, the early diagnosis and risk assessment of MM still lack convenient and effective tools for large-scale screening. In recent years, the use of matter-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) for proteomic analysis of complex biological mixtures has attracted extensive attention, and has become one of the most promising methods for the detection of m proteins. In this study, we screened the population by MALDI mass spectrometry in order to detect low level circulating M-protein by a faster and more sensitive method.
- Conditions
- Monoclonal Gammopathies, Multiple Myeloma, M-protein
- Being tested
- Observational studies, no intervention
- Keywords
- M-protein
- Medical subject headings
- Paraproteinemias, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studies, no interventionOther
Observational studies, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Multiple myeloma | Multiple myeloma (MM) is a hematologic malignant tumor characterized by abnormally cloned plasma cells in bone marrow, whose growth can lead to destructive bone injury, acute kidney injury, anemia, and hypercalcemia. Receives: Other: Observational studies, no intervention | |
| Healthy control | Individuals in good health without obvious disease and with normal physical examination report; Avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex. Receives: Other: Observational studies, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
M-protein
M-protein in urine and serum detected using MALDI-TOF Mass Spectrometry
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal GammopathiesStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Hongwei Zhou, Zhujiang Hospital
- Investigators
- Hongwei Zhou, Professor, Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686447
- Sponsor's protocol ID
- Zhujianghjd
- Status last verified
- Apr 2025
- First submitted
- 6 Jan 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis
- ClinicalTrials.gov ID
- NCT05686447
- Acronym / sponsor ID
- Zhujianghjd
- Conditions
- Monoclonal Gammopathies, Multiple Myeloma, M-protein
- Keywords
- M-protein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 17 Jan 2023 (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.
To provide a comprehensive MALDI-TOF mass spectrometry method for detecting, characterizing, and quantifying M-protein, and to track M-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment.
Detailed description
M-protein is a serum biomarker directly related to clonal plasma cell load in Multiple myeloma (MM) patients and can be used as a diagnostic marker to make out disease and a quantitative marker to track disease progression and response to treatment. Identification, typing and quantification of M-proteins are useful for initial diagnosis of disease, risk stratification and monitoring of response to treatment. Although the determination of M-protein can be used as an auxiliary diagnosis of multiple myeloma, the early diagnosis and risk assessment of MM still lack convenient and effective tools for large-scale screening. In recent years, the use of matter-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) for proteomic analysis of complex biological mixtures has attracted extensive attention, and has become one of the most promising methods for the detection of m proteins. In this study, we screened the population by MALDI mass spectrometry in order to detect low level circulating M-protein by a faster and more sensitive method.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple myeloma | – | Other: Observational studies, no interventionMultiple myeloma (MM) is a hematologic malignant tumor characterized by abnormally cloned plasma cells in bone marrow, whose growth can lead to destructive bone injury, acute kidney injury, anemia, and hypercalcemia. |
| Healthy control | – | Other: Observational studies, no interventionIndividuals in good health without obvious disease and with normal physical examination report; Avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients with Multiple myeloma hospitalized in Zhujiang hospital will be eligible to be enrolled. Also, their age- and sex- matched healthy controls making a physical examination in Zhujiang hospital will be eligible to be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studies, no interventionObservational studies, no intervention | Other | Healthy control, Multiple myeloma |
Primary outcome
M-protein
Time frame: baseline
M-protein in urine and serum detected using MALDI-TOF Mass Spectrometry
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 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Hongwei Zhou, Professor study chair
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal Gammopathies and Multiple Myeloma, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Nianyi Zeng (13928801657 ext. +86, zengny1@i.smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M-protein (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 Apr 2025.