Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-01 @ 5:20 PM
Study NCT ID:
NCT01284504
Status:
TERMINATED
Last Update Posted:
2018-03-16
First Post:
2011-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
The Effect Of Celecoxib On The Perioperative Inflammatory Response In Colon Cancer Patients - A Double-Blind Placebo-Controlled Trial
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual rate; the only participant withdrew after signing consent
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study aims to investigate how the administration of a drug known to reduce inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a patient undergoing primary tumor resection surgery for colon cancer. The proposed project is an exploratory study, and will use data from blood samples and tumor samples to attempt to elucidate the immune and inflammatory response in colon cancer patients undergoing primary resection of their tumors.
Detailed Description:
This study is the first to assess the perioperative time course of systemic inflammation and immunity in colon cancer patients and evaluate the effect of anti-inflammatory treatment with celecoxib on this response. In addition, evaluation of the effect of short-term preoperative administration of celecoxib on tumor immunogenicity will help us to understand how tumor-enhancing inflammation and anti-tumor immunity can be differentially affected by COX-2 inhibitors. The knowledge gained as a result of this research will help us to set up the infrastructure for a method to monitor the immunoinflammatory status of colon cancer patients with a longer term goal of designing interventions to suppress tumor-enhancing inflammation and vitalize anti-tumor immunity in the perioperative period. The long-term objective is to use these novel tools in order to improve cancer-specific survival in patients with colon cancer after primary tumor resection.
Study Oversight
Has Oversight DMC:
True
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?: