Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033358
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2002-04-09
Brief Title:
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Randomized phase II trial to compare two different hormone therapy regimens in preventing endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer Hormone therapy may prevent the development of endometrial cancer in women with a genetic risk for hereditary nonpolyposis colon cancer It is not yet known which hormone therapy regimen is more effective in preventing endometrial cancer
Detailed Description:
PRIMARY OBJECTIVES
I The primary objective is to evaluate the effect of progesterone therapy versus combination estrogen and progesterone therapy on potential surrogate endpoint biomarkers SEBs relevant to endometrial carcinogenesis
II To evaluate changes in histology and ultrasound appearance of the endometrium in women with HNPCC after 3 months of progesterone therapy versus combination estrogen and progesterone therapy compared with baseline
III To establish a point estimate of the baseline frequency of endometrial abnormalities looking at histological and molecular markers in a cohort of females carrying an HNPCC gene mutation
OUTLINE Patients are randomized to 1 of 2 arms
All patients undergo a baseline transvaginal ultrasound and endometrial biopsy
Arm I Patients receive medroxyprogesterone intramuscularly once on day 1 Approximately 90 days after the injection patients undergo a repeat transvaginal ultrasound and endometrial biopsy
Arm II Patients receive oral contraceptive pills OCP comprising ethinyl estradiol and norgestrel once daily on days 1-21 Treatment repeats every 28 days for 3-4 courses 3-4 packs of OCP in the absence of unacceptable toxicity Approximately 1 week after starting the fourth pack of OCP patients undergo a repeat transvaginal ultrasound and endometrial biopsy
Patients are followed at 6 weeks and are encouraged to return in 6 months to participate in continued endometrial screening
I The primary objective is to evaluate the effect of progesterone therapy versus combination estrogen and progesterone therapy on potential surrogate endpoint biomarkers SEBs relevant to endometrial carcinogenesis
II To evaluate changes in histology and ultrasound appearance of the endometrium in women with HNPCC after 3 months of progesterone therapy versus combination estrogen and progesterone therapy compared with baseline
III To establish a point estimate of the baseline frequency of endometrial abnormalities looking at histological and molecular markers in a cohort of females carrying an HNPCC gene mutation
OUTLINE Patients are randomized to 1 of 2 arms
All patients undergo a baseline transvaginal ultrasound and endometrial biopsy
Arm I Patients receive medroxyprogesterone intramuscularly once on day 1 Approximately 90 days after the injection patients undergo a repeat transvaginal ultrasound and endometrial biopsy
Arm II Patients receive oral contraceptive pills OCP comprising ethinyl estradiol and norgestrel once daily on days 1-21 Treatment repeats every 28 days for 3-4 courses 3-4 packs of OCP in the absence of unacceptable toxicity Approximately 1 week after starting the fourth pack of OCP patients undergo a repeat transvaginal ultrasound and endometrial biopsy
Patients are followed at 6 weeks and are encouraged to return in 6 months to participate in continued endometrial screening
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 |
|---|---|---|---|
| N01CN05127 | OTHER_GRANT | US NIH GrantContract Award Number | None |
| ID01-340 | None | None | None |
| CDR0000069277 | None | None | None |
| NCI-P02-0218 | None | None | None |
| MDA-ID-01340 | None | None | None |