Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084370
Status:
WITHDRAWN
Last Update Posted:
2013-08-22
First Post:
2004-06-10
Brief Title:
Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Molecular Alterations in Human Ovarian Epithelium Induced by Chemopreventive Agents in Patients at Elevated Inherited Risk of Ovarian Cancer A Controlled Pilot Study in Ovarian Cancer Chemoprevention
Status:
WITHDRAWN
Status Verified Date:
2013-08
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:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of celecoxib before prophylactic oophorectomy may be an effective way to prevent the development of ovarian epithelial cancer
PURPOSE A controlled pilot trial to study the effectiveness of celecoxib in preventing cancer in patients at high-risk for ovarian epithelial cancer who are undergoing prophylactic oophorectomy
PURPOSE A controlled pilot trial to study the effectiveness of celecoxib in preventing cancer in patients at high-risk for ovarian epithelial cancer who are undergoing prophylactic oophorectomy
Detailed Description:
OBJECTIVES
Primary
Compare histologic and molecular alterations in tissue biomarkers of patients at high risk for ovarian cancer treated with celecoxib followed by prophylactic oophorectomy vs prophylactic oophorectomy only
Secondary
Compare alterations in gene expression pattern in patients treated with these regimens
OUTLINE This is a pilot study Patients are assigned to 1 of 2 treatment groups
Group I Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy
Group II Patients undergo immediate prophylactic oophorectomy
Primary
Compare histologic and molecular alterations in tissue biomarkers of patients at high risk for ovarian cancer treated with celecoxib followed by prophylactic oophorectomy vs prophylactic oophorectomy only
Secondary
Compare alterations in gene expression pattern in patients treated with these regimens
OUTLINE This is a pilot study Patients are assigned to 1 of 2 treatment groups
Group I Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy
Group II Patients undergo immediate prophylactic oophorectomy
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 |
|---|---|---|---|
| UAB-0134 | None | None | None |