Combined Colon and Endometrial Cancer Screening in Women With HNPCC
| Tracking Information | |||||
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| First Received Date ICMJE | July 31, 2007 | ||||
| Last Updated Date | March 12, 2013 | ||||
| Start Date ICMJE | March 2002 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00510796 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combined Colon and Endometrial Cancer Screening in Women With HNPCC | ||||
| Official Title ICMJE | A Pilot Study for Combined Colon and Endometrial Cancer Screening in Women at High-Risk for Colon and Endometrial Cancer | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | UT MDACC Female patients determined to be in a high risk group for either colon and/or endometrial cancer. |
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| Condition ICMJE | Colon Cancer | ||||
| Intervention ICMJE | Behavioral: Interview
Interview regarding perception of pain and the benefits and barriers to the combined screening.
Other Name: Survey |
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| Study Group/Cohort (s) | High Risk Group
Colon and/or Endometrial Cancer
Intervention: Behavioral: Interview |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1) Women with medical indications for colonoscopy and endometrial biopsy. Exclusion Criteria: 1) Must be 18 years of age and older. |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00510796 | ||||
| Other Study ID Numbers ICMJE | ID01-694 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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