Bile Acids and Microbiome - Possible Novel Progression Factors and Diagnostic Indicators in Early Colorectal Carcinogenesis

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Currently colorectal cancer pathogenesis is mainly explained by the adenoma-carcinoma sequence theory that was proposed more than half a century ago. It mainly focuses on the explanation of genetic mutations that develop throughout the disease course. However, several studies argue that there are also noticeable bile acid metabolism changes and microbiome composition changes within in colorectal cancer patients. However, carcinoma is the final step in the sequence, and prior steps are noticeably less well studied. Thus, the investigators hypothesize, that changes within microbiome and the changes in the urine, serum and gut bile acid composition further leads to the development of colorectal adenoma and subsequent invasive carcinoma. Adult participants (15 per group) referred for colonoscopy and histologically diagnosed with small (\<1cm) adenomas, large (\>1cm) adenomas, invasive CRC will be included in the study, as well as 15 healthy controls. Fecal samples will be collected from all participants before bowel preparation. Additionally, urine and serum samples will be collected. Participants will undergo polypectomy, endoscopic mucosal resections, depending on the location, size and histology of the polyp found. During colonoscopy the mucosal biopsy specimens from the lesion and from the healthy bowel -terminal ileum, and colon will be obtained using sterile biopsy forceps. The collected samples will be stored for bile acid and microbiome analysis and for possible further pathology and genetic testing. Healthy participants without visible colorectum pathology during colonoscopy will undergo colon and terminal ileum mucosal sampling. The investigators plan to evaluate the correlation between the urine and gut microbiome changes and bile acid composition and concentration in adenoma-carcinoma sequence and possibly determine novel bile acids. In addition, fecal, urine and tissue samples will be explored for gut microbiota and bile acid composition changes in healthy and along the adenoma-carcinoma sequence, with the possibility to propose a diagnostic test.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• \- Patients that have clinical indications for colonoscopy

Locations
Other Locations
Lithuania
Vilnius University Hospital Santaros Klinikos
RECRUITING
Vilnius
Contact Information
Primary
Tomas Poskus, PhD
Tomas.Poskus@santa.lt
+37052365000
Backup
Matas Jakubauskas, PhD
Matas.Jakubauskas@santa.lt
+37052365000
Time Frame
Start Date: 2024-07-05
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 60
Treatments
Control
No pathology upon colonoscopy
Small adenoma
\< 1cm size polyp upon colonoscopy
Large adenoma
\> 1cm size polyp upon colonoscopy
Cancer
Adenocarcinoma upon colonoscopy
Sponsors
Collaborators: Vilnius University Hospital Santaros Klinikos
Leads: Vilnius University

This content was sourced from clinicaltrials.gov