Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP)

Status Not yet recruiting

Clinical Trial Summary

This is a trial that intends to evaluate the effect of treatment with the drug obeticholic acid in the treatment of the Familial Adenomatous Polyposis condition.

Clinical Trial Description

OBJECTIVES Primary Objectives -To evaluate the effect of treatment with OCA versus treatment with placebo on duodenal polyp burden (sum of polyp diameters) in participants with FAP. Secondary Objectives - To assess the safety profile of treatment with OCA versus placebo in participants with FAP. - To evaluate the effect of treatment with OCA versus placebo on rectal and pouch polyp burden (sum of polyp diameters) in participants with FAP. - To assess the effect of treatment with OCA versus placebo on polyp burden (absolute number) in the duodenum of participants with FAP. - To assess the effect of treatment with OCA versus placebo on polyp burden (absolute number) in the rectum and rectal pouch of participants with FAP. - To evaluate the effect of treatment with OCA versus placebo on serum levels of Fibroblast Growth Factor-19 (FGF19) and 7 Alpha-hydroxy-4-cholesten-3-one (7AC4, also known as C4) in participants with FAP. - To determine the effects of treatment with OCA versus placebo on gene expression in duodenal, rectal pouch, and rectal adenomas and uninvolved mucosa in participants with FAP. Identify differentially expressed genes between duodenal and colorectal adenomas and uninvolved tissue at baseline and post-intervention for participants who received OCA or placebo. Quantify the effect of OCA on the expression of downstream targets of FXR in adenomas and uninvolved tissue. Quantify the effect of OCA on the expression of cancer stem cell markers (e.g. LGR5, ASCL2, LRIG, BMI) and intestinal stem cell markers (e.g. Villin, KRT20, MUC, LYZ) in adenomas and uninvolved tissue. - To evaluate the cell-type specific effects of treatment with OCA versus placebo on gene expression and abundance in duodenal, rectal pouch, and rectal adenomas and uninvolved mucosa in participants with FAP via single-cell transcriptomics. - To evaluate the effect of treatment with OCA versus placebo on microbiome diversity in duodenal, rectal pouch, and rectal adenomas and uninvolved tissue in participants with FAP Compare alpha- and beta-diversity analysis and identify differential abundance in adenomas and uninvolved tissue. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05112822
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact	Eduardo Sanchez, MD, PhD
Phone	(713) 563-4743
Email	evilar@mdanderson.org
Status	Not yet recruiting
Phase	Phase 1
Start date	March 31, 2022
Completion date	February 28, 2024

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05630794` - Testing ONC201 to Prevent Colorectal Cancer	Phase 1
Completed	`NCT02961374` - Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer	Phase 2
Completed	`NCT01483144` - Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)	Phase 3
Completed	`NCT00641147` - Curcumin in Treating Patients With Familial Adenomatous Polyposis	Phase 2
Recruiting	`NCT03471403` - Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Not yet recruiting	`NCT04531930` - Colorectal Adenoma Canceration in FAP
Recruiting	`NCT04677998` - A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Recruiting	`NCT04678011` - A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
Completed	`NCT00927485` - Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)	N/A
Recruiting	`NCT00253812` - Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy	N/A
Withdrawn	`NCT00248053` - Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients	Phase 2
Recruiting	`NCT02012699` - Integrated Cancer Repository for Cancer Research
Completed	`NCT04674228` - Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01
Completed	`NCT01656746` - Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease	N/A
Completed	`NCT00808743` - Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis	Phase 2/Phase 3
Active, not recruiting	`NCT03847636` - CryoBalloon Ablation for Treatment of Duodenal Adenomas	N/A
Recruiting	`NCT02656134` - Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)	N/A
Withdrawn	`NCT01245816` - A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)	Phase 3
Recruiting	`NCT04709445` - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses	N/A
Enrolling by invitation	`NCT05402891` - The CHAMP-study: The CHemopreventive Effect of Lithium in Familial AdenoMatous Polyposis	Phase 2