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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00510796 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Colon Cancer |
Behavioral: Interview |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Pilot Study for Combined Colon and Endometrial Cancer Screening in Women at High-Risk for Colon and Endometrial Cancer |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2002 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
High Risk Group
Colon and/or Endometrial Cancer
|
Behavioral: Interview
Interview regarding perception of pain and the benefits and barriers to the combined screening.
Other Name: Survey
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
UT MDACC Female patients determined to be in a high risk group for either colon and/or endometrial cancer.
Inclusion Criteria:
1) Women with medical indications for colonoscopy and endometrial biopsy.
Exclusion Criteria:
1) Must be 18 years of age and older.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Karen H. Lu, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00510796 History of Changes |
| Other Study ID Numbers: | ID01-694 |
| Study First Received: | July 31, 2007 |
| Last Updated: | November 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Hereditary Non-Polyposis Colon Cancer Colon Cancer Endometrial Cancer |
Cancer Screening Interview HNPCC |
|
Colonic Neoplasms Endometrial Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases Genital Diseases, Female |
