NCT06690593Recruiting
Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy
Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2990 (estimated)
- First submitted
- 13 Nov 2024
- Start date
- 26 Dec 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Zhujiang Hospital
- Diseases
- Multiple myeloma
- NCT number
- NCT06690593
What you commit to
- Study type: Observational
- Planned participants: 2990
- From 26 Dec 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- (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.
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.