Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502704
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-17
Brief Title:
Bile Acids and Microbiome in Early Colorectal Carcinogenesis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bile Acids and Microbiome - Possible Novel Progression Factors and Diagnostic Indicators in Early Colorectal Carcinogenesis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None