Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920149
Status:
RECRUITING
Last Update Posted:
2022-03-28
First Post:
2021-06-03
Brief Title:
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Sponsor:
Ann-Sofie Backman
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Status:
RECRUITING
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MesaCAPP
Brief Summary:
Multicenter multinational randomized 2-arm double-blind phase II clinical study with 2000mg mesalamine or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients during and following daily intake for 2 years
Detailed Description:
This is a multicenter multinational randomized 2-arm double-blind phase II clinical study with 2000mg mesalamine 5-ASA or placebo in LS patients for a 2-year treatment 260 tumor free carriers of a known genetic mutation in a major MMR gene including patients in which the polyps are endoscopically removed will be randomized 11 to receive 2000mg mesalamine or placebo Patients will be identified through local or national registries and through collaboration with sites Tumor free patients assessed by white light high resolution colonoscopy will be randomized to the study Blood and stool samples will be collected for analysis of microbiota ctDNA and potential biomarkers Biopsies of the normal tissue of ascending colon and rectum will be taken at the first and the last colonoscopy
The aim of the study is to investigate the effect of regular treatment with mesalamine 5-ASA on the occurrence of any colorectal neoplasia tumor multiplicity the number of detected adenomascarcinomas and tumor progression in LS patients
Tumor multiplicity and tumor progression severity of the neoplastic lesions will be investigated
The aim of the study is to investigate the effect of regular treatment with mesalamine 5-ASA on the occurrence of any colorectal neoplasia tumor multiplicity the number of detected adenomascarcinomas and tumor progression in LS patients
Tumor multiplicity and tumor progression severity of the neoplastic lesions will be investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None