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Combined Colon and Endometrial Cancer Screening in Women With HNPCC

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified

Screening

Active

Not specified

Other

ID01-694
NCT00510796

Trial Description

Summary

Primary Objectives:

1. To test the feasibility of combined colon and endometrial cancer screening in women with increased risk for colon and endometrial cancer.

2. To measure patient satisfaction for the combined procedure.

Further Study Information

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 you must have a negative blood 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.

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria: None

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Karen H. Lu

Principal Investigator

Karen H. Lu, MD

Ph: 713-745-8902

Trial Sites

U.S.A.

Texas

Houston

M. D. Anderson Cancer Center at University of Texas

Karen H. Lu Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00510796
Information obtained from ClinicalTrials.gov on October 15, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.