Monoclonal Gammopathy of Undetermined Significance (MGUS)NCT06690593
Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy
An observational study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Intestinal Flora, run by Zhujiang Hospital at 1 site in China.
Trial summary
This is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Intestinal Flora, Multiple Myeloma
- How many people
- 2,990 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2024to 30 Dec 2026
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of patients aged 45 years and older who meet the following inclusion criteria: 1. Confirmed negative for monoclonal immunoglobulin by MALDI-TOF MS screening. 2. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study. 3. Availability of sufficient whole blood, plasma, serum, and fecal samples, as well as relevant case information. Exclusion criteria include: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease. 2. Received antibiotic treatment within the last month. 3. Presence of severe systemic diseases, including malignant tumors, insufficient sample volume, or presence of sample failure (e.g., severe hemolysis, lipemia, or jaundice).
(I) Inclusion Criteria:
- Age 45 years or older;
- Negative screening for monoclonal protein by MALDI-TOF MS;
- No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study;
- Sufficient whole blood, plasma, serum, and stool samples available, and relevant case data can be provided. (II) Exclusion Criteria:
- History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization;
- Antibiotic treatment received in the past month; Presence of severe systemic diseases, including malignant tumors;
- Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hongwei Zhou, Professor contact
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, 510280
Hongwei Zhou, Professor, 186 8848 9622, hzhou@smu.edu.cn
About this study
Official title: Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression
This is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). The study will collect blood and stool samples from MGUS patients, non-MGUS patients (with similar diseases), and healthy controls, and perform multi-omics detection including microbiomics, peptidomics, and biochemical immunology. It will comprehensively analyze the abnormal features of the gut microbiome in MGUS patients, which may help provide new biomarkers and potential mechanisms for the diagnosis, prognosis evaluation, and treatment strategies of MGUS.
Read the detailed description
This is a case-control, observational single-center study aiming to investigate the impact of common comorbidities on gut microbiome structure and disease progression in patients with monoclonal gammopathy. We plan to collect samples from 11 disease categories, with each category including two groups (monoclonal gammopathy and non-monoclonal gammopathy), as well as 700 age- and gender-matched healthy controls, for a total of 2,990 samples. At enrollment, we will collect whole blood, plasma, serum, and fecal samples from the study participants, and obtain relevant information such as demographic characteristics, lifestyle, family medical history, and medication use.We will perform metagenomic, proteomic, and serum biochemical and immunological analyses on the samples to directly obtain association data between gut microbiome characteristics (as exposure factors) and clinical outcomes (as endpoints). This study will systematically analyze the dysbiosis characteristics of the gut microbiome in monoclonal gammopathy patients, identify key microbial biomarkers, and compare the microbiome structure and clinical laboratory indices between MGUS patients and different comorbidity subgroups, to explore their impact on the disease diagnostic model.
- Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Intestinal Flora, Multiple Myeloma, M-Protein
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, 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 |
|---|---|---|
| Monoclonal gammopathy patients | (I) Inclusion Criteria: 1. Age 45 years or older. 2. Positive screening for monoclonal protein by MALDI-TOF MS. 3. Meeting the International Classification of Diseases, 11th Revision (ICD-11) criteria for one of the following disease types:Infectious diseases，Tumors，Blood or hematopoietic organ diseases，Immune system diseases，Endocrine, nutritional, or metabolic diseases，Nervous system diseases，Circulatory system diseases，Respiratory system diseases，Digestive system diseases，Musculoskeletal or connective tissue diseases，Urinary and reproductive system diseases. 4. Sufficient whole blood, plasma, serum, and stool samples available, with relevant case data provided. (II) Exclusion Criteria: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization. 2. Antibiotic treatment in the past month. 3. Insufficient sample volume, or severe hemolysis, lipemia, jaundice, or other unqualified sample conditions. | |
| Non-monoclonal gammopathy patients | (I) Inclusion Criteria: 1. Age 45 years or older. 2. Negative screening for monoclonal protein by MALDI-TOF MS. 3. Patients meeting ICD-11 criteria for one of the following disease types:Infectious diseases，Tumors，Blood or hematopoietic organ diseases，Immune system diseases，Endocrine, nutritional, or metabolic diseases，Nervous system diseases，Circulatory system diseases，Respiratory system diseases，Digestive system diseases，Musculoskeletal or connective tissue diseases，Urinary and reproductive system diseases. 4. Sufficient whole blood, plasma, serum, and stool samples available, with relevant case data provided. (II) Exclusion Criteria: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization. 2. Antibiotic treatment in the past month. 3. Insufficient sample volume, or severe hemolysis, lipemia, jaundice, or other unqualified sample conditions. | |
| Healthy control group | (I) Inclusion Criteria: 1. Age 45 years or older. 2. Negative screening for monoclonal protein by MALDI-TOF MS. 3. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study. 4. Sufficient whole blood, plasma, serum, and stool samples available, and relevant case data can be provided. (II) Exclusion Criteria: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization. 2. Antibiotic treatment received in the past month. Presence of severe systemic diseases, including malignant tumors. 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
M-protein detection
Plasma samples from all patients will be screened and qualitatively analysed for M proteins using MALDI-TOF MS to determine the presence of patients with monoclonal gammaglobulinemia.
Measured: 24 months
microbiome
To assess the value of the microbiome in predicting the prognosis of patients with monoclonal gammopathy and in diagnosing co-morbidities. To analyse the microbial composition of patient stool samples using 16S rRNA gene sequencing and metagenomics.
Measured: 24 months
metabonomics
To assess changes in plasma metabolomics in patients with monoclonal gammaglobulinaemia. Metabolomics is a large-scale study of small molecules such as fatty acids, bile acids, and lipid mediators.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start26 Dec 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Undetermined Significance (MGUS)Studies 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
- Retrospective
- Enrolment
- 2,990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwei Zhou, Professor, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690593
- Sponsor's protocol ID
- ZhujiangGMMGUS
- Status last verified
- Jul 2024
- First submitted
- 13 Nov 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression
- ClinicalTrials.gov ID
- NCT06690593
- Acronym / sponsor ID
- ZhujiangGMMGUS
- Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Intestinal Flora, Multiple Myeloma, M-Protein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,990 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 26 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Nov 2024 (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.
This is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). The study will collect blood and stool samples from MGUS patients, non-MGUS patients (with similar diseases), and healthy controls, and perform multi-omics detection including microbiomics, peptidomics, and biochemical immunology. It will comprehensively analyze the abnormal features of the gut microbiome in MGUS patients, which may help provide new biomarkers and potential mechanisms for the diagnosis, prognosis evaluation, and treatment strategies of MGUS.
Detailed description
This is a case-control, observational single-center study aiming to investigate the impact of common comorbidities on gut microbiome structure and disease progression in patients with monoclonal gammopathy. We plan to collect samples from 11 disease categories, with each category including two groups (monoclonal gammopathy and non-monoclonal gammopathy), as well as 700 age- and gender-matched healthy controls, for a total of 2,990 samples. At enrollment, we will collect whole blood, plasma, serum, and fecal samples from the study participants, and obtain relevant information such as demographic characteristics, lifestyle, family medical history, and medication use.We will perform metagenomic, proteomic, and serum biochemical and immunological analyses on the samples to directly obtain association data between gut microbiome characteristics (as exposure factors) and clinical outcomes (as endpoints). This study will systematically analyze the dysbiosis characteristics of the gut microbiome in monoclonal gammopathy patients, identify key microbial biomarkers, and compare the microbiome structure and clinical laboratory indices between MGUS patients and different comorbidity subgroups, to explore their impact on the disease diagnostic model.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monoclonal gammopathy patients | – | –(I) Inclusion Criteria: 1. Age 45 years or older. 2. Positive screening for monoclonal protein by MALDI-TOF MS. 3. Meeting the International Classification of Diseases, 11th Revision (ICD-11) criteria for one of the following disease types:Infectious diseases，Tumors，Blood or hematopoietic organ diseases，Immune system diseases，Endocrine, nutritional, or metabolic diseases，Nervous system diseases，Circulatory system diseases，Respiratory system diseases，Digestive system diseases，Musculoskeletal or connective tissue diseases，Urinary and reproductive system diseases. 4. Sufficient whole blood, plasma, serum, and stool samples available, with relevant case data provided. (II) Exclusion Criteria: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization. 2. Antibiotic treatment in the past month. 3. Insufficient sample volume, or severe hemolysis, lipemia, jaundice, or other unqualified sample conditions. |
| Non-monoclonal gammopathy patients | – | –(I) Inclusion Criteria: 1. Age 45 years or older. 2. Negative screening for monoclonal protein by MALDI-TOF MS. 3. Patients meeting ICD-11 criteria for one of the following disease types:Infectious diseases，Tumors，Blood or hematopoietic organ diseases，Immune system diseases，Endocrine, nutritional, or metabolic diseases，Nervous system diseases，Circulatory system diseases，Respiratory system diseases，Digestive system diseases，Musculoskeletal or connective tissue diseases，Urinary and reproductive system diseases. 4. Sufficient whole blood, plasma, serum, and stool samples available, with relevant case data provided. (II) Exclusion Criteria: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization. 2. Antibiotic treatment in the past month. 3. Insufficient sample volume, or severe hemolysis, lipemia, jaundice, or other unqualified sample conditions. |
| Healthy control group | – | –(I) Inclusion Criteria: 1. Age 45 years or older. 2. Negative screening for monoclonal protein by MALDI-TOF MS. 3. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study. 4. Sufficient whole blood, plasma, serum, and stool samples available, and relevant case data can be provided. (II) Exclusion Criteria: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization. 2. Antibiotic treatment received in the past month. Presence of severe systemic diseases, including malignant tumors. 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients aged 45 years and older who meet the following inclusion criteria: 1. Confirmed negative for monoclonal immunoglobulin by MALDI-TOF MS screening. 2. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study. 3. Availability of sufficient whole blood, plasma, serum, and fecal samples, as well as relevant case information. Exclusion criteria include: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease. 2. Received antibiotic treatment within the last month. 3. Presence of severe systemic diseases, including malignant tumors, insufficient sample volume, or presence of sample failure (e.g., severe hemolysis, lipemia, or jaundice).
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
M-protein detection
Time frame: 24 months
Plasma samples from all patients will be screened and qualitatively analysed for M proteins using MALDI-TOF MS to determine the presence of patients with monoclonal gammaglobulinemia.
microbiome
Time frame: 24 months
To assess the value of the microbiome in predicting the prognosis of patients with monoclonal gammopathy and in diagnosing co-morbidities. To analyse the microbial composition of patient stool samples using 16S rRNA gene sequencing and metagenomics.
metabonomics
Time frame: 24 months
To assess changes in plasma metabolomics in patients with monoclonal gammaglobulinaemia. Metabolomics is a large-scale study of small molecules such as fatty acids, bile acids, and lipid mediators.
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 27 Dec 2024.
- 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 contact
Hongwei Zhou, Professor study chair
Southern Medical University, China
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 Gammopathy of Undetermined Significance (MGUS) and Intestinal Flora, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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, 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 detection (time frame: 24 months). The study lists 3 primary outcomes in all. 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 27 Dec 2024.