Assessment of Screening Modalities for Gynecologic Cancers
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First Received Date ICMJE | April 10, 2009 | ||||||||
Last Updated Date | March 14, 2012 | ||||||||
Start Date ICMJE | April 2009 | ||||||||
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Change History | Complete list of historical versions of study NCT00879840 on ClinicalTrials.gov Archive Site | ||||||||
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Descriptive Information | |||||||||
Brief Title ICMJE | Assessment of Screening Modalities for Gynecologic Cancers | ||||||||
Official Title ICMJE | Assessment of Screening Modalities for Gynecologic Cancers | ||||||||
Brief Summary | Background:
Objectives:
Eligibility:
Design:
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Detailed Description | Background: Currently, there are no convincing early detection approaches for endometrial and ovarian cancers. Although it is well established that some endometrial and ovarian tumors shed cytologically recognizable cells in routinely prepared Pap tests, it is clear that this approach rarely detects occult tumors. Accordingly, efforts to develop means of collecting biological samples that have high patient acceptability, good sensitivity for detecting early disease, and excellent specificity are needed. Objectives: In this project, we want to assess the feasibility of using alternative sampling techniques in combination with molecular assays to detect endometrial and ovarian cancers. We will compare sampling using a Tampon and a sheathed endometrial brush, the Tao brush. We want to assess the quality of DNA extracted from the different samplers. We will assess the correlations between methylation of somatic DNA for a selected marker panel and cancer status. Eligibility: We wish to include 117 women age 45 years and older with suspected endometrial cancer, or ovarian cancer, and 53 age-matched (plus/minus 5 years) controls without malignancy, all of whom are referred to surgery at the Mayo clinic. Design: We plan to conduct a pilot study of women with confirmed or suspected endometrial cancer, or ovarian cancer, and women treated for benign conditions. DNA will be extracted from samples collected using a vaginal Tampon and an endometrial brushing using an FDA approved device (Tao brush) prior to surgery. A panel of methylation markers will be analyzed from samples yielding sufficient DNA. The results of the methylation analysis will be compared to the final histology for all patients in the study. We will set the detection of methylation at one or more loci in 50% of women in each arm as a technical success. |
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Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | Time Perspective: Retrospective | ||||||||
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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 | Recruiting | ||||||||
Estimated Enrollment ICMJE | 170 | ||||||||
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Eligibility Criteria ICMJE |
EXCLUSION CRITERIA:
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Gender | Female | ||||||||
Ages | 50 Years and older | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00879840 | ||||||||
Other Study ID Numbers ICMJE | 999909121, 09-C-N121 | ||||||||
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Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||||||
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Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | November 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |