Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118989
Status:
TERMINATED
Last Update Posted:
2017-04-20
First Post:
2005-07-02
Brief Title:
Curcumin for the Chemoprevention of Colorectal Cancer
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Phase II Double Blind Placebo-Controlled Trial of Curcuminoids Effect on Cellular Proliferation Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects With Recently Resected Sporadic Adenomatous Polyps
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Could not be completed due to technology problems and cost constraints
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Specific Aims
To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen PCNA in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps
Hypothesis Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps
To determine if curcuminoids modulate apoptosis as measured by TUNEL assay in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps
Hypothesis Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps
To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps
Hypothesis Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps
To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids
Hypothesis Curcuminoids decrease concentrations of urinary eicosanoids
To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen PCNA in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps
Hypothesis Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps
To determine if curcuminoids modulate apoptosis as measured by TUNEL assay in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps
Hypothesis Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps
To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps
Hypothesis Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps
To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids
Hypothesis Curcuminoids decrease concentrations of urinary eicosanoids
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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