Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510796
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2007-07-31
Brief Title:
Combined Colon and Endometrial Cancer Screening in Women With HNPCC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Study for Combined Colon and Endometrial Cancer Screening in Women at High-Risk for Colon and Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2016-02
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:
Primary Objectives
To test the feasibility of combined colon and endometrial cancer screening in women with increased risk for colon and endometrial cancer
To measure patient satisfaction for the combined procedure
To test the feasibility of combined colon and endometrial cancer screening in women with increased risk for colon and endometrial cancer
To measure patient satisfaction for the combined procedure
Detailed Description:
Women with certain medical conditions have an increased risk for colon and endometrial cancer Currently women go through separate screening procedures Endometrial biopsies are performed at a separate visit to the gynecologist and patients are not sedated for the procedure This study will involve performing an endometrial biopsy while you are sedated for your colonoscopy
Women who are able to have children must have a negative blood or urine pregnancy test before they can take part in this study
As part of the study you will be asked about your past experience with endometrial biopsy and colonoscopy You will be asked about your perception of pain your expectations and the benefits and barriers to the combined screening
You will then be sedated The colonoscopy will be performed first by a gastroenterologist This will be followed by the endometrial biopsy which will be performed by a gynecologic oncologist
A telephone interview will be performed two weeks after this procedure The interview will last about 15 minutes You will be asked about your perception of pain and the benefits and barriers to the combined screening
This is an investigational study A total of 50 women will take part in this study All will be enrolled at M D Anderson
Women who are able to have children must have a negative blood or urine pregnancy test before they can take part in this study
As part of the study you will be asked about your past experience with endometrial biopsy and colonoscopy You will be asked about your perception of pain your expectations and the benefits and barriers to the combined screening
You will then be sedated The colonoscopy will be performed first by a gastroenterologist This will be followed by the endometrial biopsy which will be performed by a gynecologic oncologist
A telephone interview will be performed two weeks after this procedure The interview will last about 15 minutes You will be asked about your perception of pain and the benefits and barriers to the combined screening
This is an investigational study A total of 50 women will take part in this study All will be enrolled at M D Anderson
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