Combined Colon and Endometrial Cancer Screening in Women With HNPCC

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with medical indications for colonoscopy and endometrial biopsy.

Exclusion criteria

Must be 18 years of age and older.

Treatment and study plan

Interview

Behavioral

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

Other names: Survey

Primary outcomes

Feasibility to perform both colon and endometrial cancer screening at the time of colonoscopy in women at high risk for colon and endometrial cancer.

Time frame: 8 Years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2015
Study completion: 2015
First posted: Aug 2, 2007
Registry last updated: Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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