Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00468910
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2007-05-02
Brief Title:
Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia
Status:
COMPLETED
Status Verified Date:
2017-04
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:
None
Brief Summary:
This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer Chemoprevention is the use of certain drugs to keep cancer from forming The use of aspirin may prevent colorectal cancer
Detailed Description:
PRIMARY OBJECTIVE
I Determine whether acetylsalicylic acid aspirin will alter spectral markers ie spectral slope and fractal dimension in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer
SECONDARY OBJECTIVES
I Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in these patients
II Assess the effect of this drug on rectal prostaglandin levels in these patients
III Assess the effect of this drug on platelet cyclooxygenase activity in these patients
IV Correlate changes in spectral markers with UGT1A6 genotype in patients treated with this drug
OUTLINE This is a multicenter randomized double-blind placebo-controlled study Patients are stratified by clinical site and adenomacarcinoma maximal size Patients with abnormal spectral biomarkers are randomized to 1 of 2 treatment arms
ARM I Patients receive oral acetylsalicylic acid aspirin once daily
ARM II Patients receive oral placebo once daily
In both arms treatment continues for 3 months in the absence of unacceptable toxicity
Patients undergo flexible sigmoidoscopy and biopsies as well as blood collection at baseline during prestudy colonoscopy and at completion of study treatment for comparison of spectral signatures with biomarkers of both aspirin activity including plasma cyclooxygenase activity and rectal prostaglandin levels as well as with biomarkers associated with antineoplastic alteration including apoptosis and cell proliferation UGT1A6 genotyping analysis is also performed
After completion of study treatment patients are followed at 3 months
I Determine whether acetylsalicylic acid aspirin will alter spectral markers ie spectral slope and fractal dimension in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer
SECONDARY OBJECTIVES
I Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in these patients
II Assess the effect of this drug on rectal prostaglandin levels in these patients
III Assess the effect of this drug on platelet cyclooxygenase activity in these patients
IV Correlate changes in spectral markers with UGT1A6 genotype in patients treated with this drug
OUTLINE This is a multicenter randomized double-blind placebo-controlled study Patients are stratified by clinical site and adenomacarcinoma maximal size Patients with abnormal spectral biomarkers are randomized to 1 of 2 treatment arms
ARM I Patients receive oral acetylsalicylic acid aspirin once daily
ARM II Patients receive oral placebo once daily
In both arms treatment continues for 3 months in the absence of unacceptable toxicity
Patients undergo flexible sigmoidoscopy and biopsies as well as blood collection at baseline during prestudy colonoscopy and at completion of study treatment for comparison of spectral signatures with biomarkers of both aspirin activity including plasma cyclooxygenase activity and rectal prostaglandin levels as well as with biomarkers associated with antineoplastic alteration including apoptosis and cell proliferation UGT1A6 genotyping analysis is also performed
After completion of study treatment patients are followed at 3 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CN35157 | NIH | DCP | httpsreporternihgovquickSearchN01CN35157 |
| NCI-2009-00841 | REGISTRY | None | None |
| CDR0000652929 | None | None | None |
| NCI 04-2-03 | OTHER | None | None |
| NWU04-2-03 | OTHER | None | None |