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

NCT06690593 | Recruiting

• 1 other identifier: ZhujiangGMMGUS
• Study Type: observational
• Target: 2,990
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance; Multiple Myeloma

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders

Study Officials

• Hongwei Zhou, Professor

  Southern Medical University, China

  STUDY CHAIR

Central Study Contacts

Nianyi Zeng

CONTACT

13928801657; zengny1@i.smu.edu.cn

Hongwei Zhou, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)