Viewing Study NCT06614738



Ignite Creation Date: 2024-10-25 @ 7:52 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06614738
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-24

Brief Title: Microbial and Environmental Factors Associated with Polyps Development in Familial Adenomatous Polyposis MicrobEnvironment in FAP
Sponsor: None
Organization: None

Study Overview

Official Title: Microbial and Environmental Factors Associated with Polyps Development in Familial Adenomatous Polyposis
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
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: Familial adenomatous polyposis FAP is an autosomal dominant inherited disorder linked to a mutation in the APC gene associated with the development of multiple colonic and duodenal adenomas which in 100 of cases progress to colorectal cancer CRC if left untreated Management of affected patients is usually based on prophylactic total colectomy with or without rectal preservation followed by regular endoscopic surveillance of the duodenum and rectum or ileal reservoir However there is considerable inter- and intra-familial variability in the rate of adenoma appearance and development for identical mutations This strongly suggests the additional role of environmental factors Recently the gut microbiota has been identified as a co-factor of carcinogenesis in patients with FAP but no prospective evaluation of the association between the incidence and severity of adenomatous proliferations and a microbiological signature has been studied particularly at duodenal level in operated patient
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