Combined Colon and Endometrial Cancer Screening in Women With HNPCC

Colon Cancer Clinical Trial

Official title:

A Pilot Study for Combined Colon and Endometrial Cancer Screening in Women at High-Risk for Colon and Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510796
• Other study ID #: ID01-694
• Status: Completed
• Phase: N/A
• First received: July 31, 2007
• Last updated: February 15, 2016
• Start date: March 2002
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1) Women with medical indications for colonoscopy and endometrial biopsy.

Exclusion Criteria:

1) Must be 18 years of age and older.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Behavioral:
• Interview
Interview regarding perception of pain and the benefits and barriers to the combined screening.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility to perform both colon and endometrial cancer screening at the time of colonoscopy in women at high risk for colon and endometrial cancer.		8 Years	No

External Links

•   The University of Texas M.D.Anderson Cancer Center