NCT06690593 Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy
| NCT ID | NCT06690593 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Monoclonal Gammopathy of Undetermined Significance (MGUS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,990 participants |
| Start Date | 2024-12-26 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,990 participants in total. It began in 2024-12-26 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
(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.
Contact & Investigator
Hongwei Zhou, Professor
STUDY CHAIR
Southern Medical University, China
Frequently Asked Questions
Who can join the NCT06690593 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Monoclonal Gammopathy of Undetermined Significance (MGUS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06690593 currently recruiting?
Yes, NCT06690593 is actively recruiting participants. Contact the research team at zengny1@i.smu.edu.cn for enrollment information.
Where is the NCT06690593 trial being conducted?
This trial is being conducted at Guanzhou, China.
Who is sponsoring the NCT06690593 clinical trial?
NCT06690593 is sponsored by Zhujiang Hospital. The principal investigator is Hongwei Zhou, Professor at Southern Medical University, China. The trial plans to enroll 2,990 participants.