Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003598
Status:
COMPLETED
Last Update Posted:
2010-09-22
First Post:
1999-11-01
Brief Title:
UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Retinoids and Intermediate Biomarkers for CIN II and III Pilot Trial
Status:
COMPLETED
Status Verified Date:
2010-09
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:
IRB 1996-0189
Brief Summary:
RATIONALE Tretinoin may help cervical neoplasia cells develop into normal cervical cells It is not yet known whether tretinoin is more effective than a placebo in preventing cervical cancer in patients with cervical neoplasia
PURPOSE Randomized clinical trial to study the effectiveness of tretinoin in preventing cervical neoplasia from developing into cervical cancer
PURPOSE Randomized clinical trial to study the effectiveness of tretinoin in preventing cervical neoplasia from developing into cervical cancer
Detailed Description:
OBJECTIVES I Determine whether topical tretinoin reduces the number of viral genome copies of human papilloma virus HPV per cell and inhibits HPV E6E7 gene expression in patients with cervical dysplasia II Determine the dose of tretinoin for use in a definitive trial that produces the best overall modulation of these biomarkers
OUTLINE This is a randomized multicenter study Patients are stratified according to cervical intraepithelial neoplasia classification II vs III Patients are randomized to 1 of 4 arms Arm I Patients receive low-dose tretinoin topically via cervical cap and polyurethane ether foam sponge changed daily for 4 days Arm II Patients receive intermediate-dose tretinoin as in arm I Arm III Patients receive high-dose tretinoin as in arm I Arm IV Patients receive placebo topically as in arm I therapy Patients are followed for 6 months
PROJECTED ACCRUAL A total of 180 patients 45 per arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to cervical intraepithelial neoplasia classification II vs III Patients are randomized to 1 of 4 arms Arm I Patients receive low-dose tretinoin topically via cervical cap and polyurethane ether foam sponge changed daily for 4 days Arm II Patients receive intermediate-dose tretinoin as in arm I Arm III Patients receive high-dose tretinoin as in arm I Arm IV Patients receive placebo topically as in arm I therapy Patients are followed for 6 months
PROJECTED ACCRUAL A total of 180 patients 45 per arm will be accrued for this study
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 |
|---|---|---|---|
| NCI-P98-0131 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA046592 |
| P30CA046592 | NIH | None | None |
| CCUM-9609 | None | None | None |