Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01911247
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2013-07-23
Brief Title:
Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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:
The overall goal of this proposal is to investigate the potential benefit of metformin as a novel therapy for the treatment of endometrial cancer Investigators will evaluate the effect of short-term metformin treatment on the endometrium of obese women with endometrial cancer by comparing each patients endometrial biopsy before treatment with metformin to their post-treatment hysterectomy specimen
Participants Obese women who are to undergo surgical staging for endometrial cancer will also receive short-term treatment 1-4 weeks with metformin that will continue until the day prior to surgical staging
The effect of metformin on proliferation apoptosis and downstream signaling pathways will be compared between pre-treatment endometrial biopsies and post-treatment hysterectomy specimens Tissue microarrays will be constructed and immunohistochemstry performed to evaluate proliferation apoptosis and changes in critical signaling pathways mediated by metformin and these findings will be correlated with our in vitro preclinical studies Fresh tissue will also be obtained and Western immunoblotting will be used to assess expression of the phosphorylated forms of the downstream targets of metformin The hypothesis is that treatment with metformin will result in a decrease in proliferative markers and an increase in markers of apoptosis in the endometrial cancer tumors AMPK phosphorylation and inhibition of critical downstream targets of the mTOR pathway will be seen in the post-treatment hysterectomy specimens Metabolomic profiling will also be performed of tumors and associated biofluids ie serum and urine before and after treatment with metformin to identify potential biomarkers of response to this therapy
Participants Obese women who are to undergo surgical staging for endometrial cancer will also receive short-term treatment 1-4 weeks with metformin that will continue until the day prior to surgical staging
The effect of metformin on proliferation apoptosis and downstream signaling pathways will be compared between pre-treatment endometrial biopsies and post-treatment hysterectomy specimens Tissue microarrays will be constructed and immunohistochemstry performed to evaluate proliferation apoptosis and changes in critical signaling pathways mediated by metformin and these findings will be correlated with our in vitro preclinical studies Fresh tissue will also be obtained and Western immunoblotting will be used to assess expression of the phosphorylated forms of the downstream targets of metformin The hypothesis is that treatment with metformin will result in a decrease in proliferative markers and an increase in markers of apoptosis in the endometrial cancer tumors AMPK phosphorylation and inhibition of critical downstream targets of the mTOR pathway will be seen in the post-treatment hysterectomy specimens Metabolomic profiling will also be performed of tumors and associated biofluids ie serum and urine before and after treatment with metformin to identify potential biomarkers of response to this therapy
Detailed Description:
None
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 |
|---|---|---|---|
| 1K23CA143154-01A1 | NIH | None | httpsreporternihgovquickSearch1K23CA143154-01A1 |