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Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy

NCT ID: NCT06690593

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2990 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-26

Study Completion Date

2026-12-30

Brief Summary

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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

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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

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Monoclonal Gammopathy of Undetermined Significance (MGUS) Intestinal Flora Multiple Myeloma M-Protein

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.

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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongwei Zhou, Professor

Role: STUDY_CHAIR

Southern Medical University, China

Locations

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Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nianyi Zeng

Role: CONTACT

Phone: 13928801657

Email: [email protected]

Hongwei Zhou, Professor

Role: CONTACT

Facility Contacts

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Hongwei Zhou, Professor

Role: primary

Other Identifiers

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ZhujiangGMMGUS

Identifier Type: -

Identifier Source: org_study_id