Actively Recruiting
Bile Acids and Microbiome - Possible Novel Progression Factors and Diagnostic Indicators in Early Colorectal Carcinogenesis
Led by Vilnius University · Updated on 2024-07-16
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vilnius University
Lead Sponsor
V
Vilnius University Hospital Santaros Klinikos
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the role of bile acid metabolism and microbiome changes in the early stages of colorectal cancer development. While genetic mutations in the adenoma-carcinoma sequence have been widely studied, this research focuses on how alterations in urine, serum, and gut bile acid composition, along with microbiome changes, may contribute to the progression from adenomas to invasive carcinoma. The study includes adults referred for colonoscopy, categorized by polyp size and cancer presence, along with healthy controls. Participants will undergo colonoscopy with sample collection before bowel preparation, including fecal, urine, and serum samples. During the procedure, biopsies will be taken from lesions and healthy bowel areas such as the terminal ileum and colon. Treatments like polypectomy or endoscopic mucosal resection will be performed based on polyp characteristics. Samples will be stored for bile acid and microbiome analysis and potential genetic or pathology testing. Throughout an average of two years, researchers will evaluate the relationship between microbiome and bile acid changes and dysplastic progression. They will analyze bile acid composition in urine, stool, serum, and tissue samples from both healthy individuals and those along the adenoma-carcinoma sequence. The study aims to identify novel bile acids and possibly develop new diagnostic tests for early colorectal carcinogenesis.
CONDITIONS
Brief Title
Bile Acids and Microbiome in Early Colorectal Carcinogenesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients that have clinical indications for colonoscopy
You will not qualify if you...
- Pregnancy
- Immunocompromised
- Previously diagnosed colorectal diseases
- Radiotherapy to the pelvis
- Long term antibiotic use within 6 months
- Continuous use of proton pump inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo colonoscopy to assess colorectal pathology and assign study groups based on findings.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed over time to monitor microbiome and bile acid composition in relation to colorectal changes.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania, 08661
Actively Recruiting
Research Team
T
Tomas Poskus, PhD
M
Matas Jakubauskas, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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