Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172367
Status:
WITHDRAWN
Last Update Posted:
2008-09-26
First Post:
2005-09-12
Brief Title:
Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was for National Science Council project The study was not funded so the study was withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma
Secondary Objective To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients
Secondary Objective To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients
Detailed Description:
This is a renal function-stratified phase II chemoprevention trial After 8 weeks of a run-in and washout period participants will take lycopene 30 mg per day for 12 weeks The expression of intermediate biomarkers will be determined upon study entry after 8 weeks of run-inwashout and after 6 and 12 weeks of lycopene supplementation It takes at least 20 weeks to complete the course
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