Assessment of Screening Modalities for Gynecologic Cancers
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|ClinicalTrials.gov Identifier: NCT00879840|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2009
Last Update Posted : September 5, 2018
- Endometrial and ovarian cancers are, respectively, the fourth and eighth most common cancers among women in the United States. Although some routine Pap tests may detect the presence of cancer cells, there are no convincing early detection approaches for either cancer. Better methods of detection are needed.
- Two possible methods for cancer detection involve samples taken with a tampon or a special kind of brush, called a Tao brush. Researchers would like to know more about how well these methods work.
- To assess the quality of DNA collected by the tampon and Tao brush sampling methods.
- To detect genetic markers in collected DNA and determine if these markers are related to an individual s cancer status.
- Women age 45 years and older with confirmed or suspected endometrial or ovarian cancer, who will be having surgery.
- A control group of postmenopausal women having surgery for benign gynecological conditions will be included.
- Shortly before hysterectomy or more extensive procedures to treat either cancer or the benign condition:
- A tampon will be inserted into the vagina to collect cell samples, and removed after 30 minutes.
- After the tampon is removed, the cervix will be swabbed with the Tao brush to collect cell samples.
- Following the hysterectomy, samples of healthy and cancerous tissue will be taken, and tested by researchers.
|Condition or disease|
|Ovarian Cancer Endometrial Cancer Controls Without Endometrial Cancer Controls Without Ovarian Cancer|
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.
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.
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||118 participants|
|Official Title:||Assessment of Screening Modalities for Gynecologic Cancers|
|Study Start Date :||April 9, 2009|
- The primary outcome measures are: Detection of endometrial cancer or ovarian cancer [ Time Frame: Detection of endometrial or ovarian cancer at the surgery after the study sample has been taken. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879840
|United States, Minnesota|
|Mayo Clinic, Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Nicolas Wentzensen, M.D.||National Cancer Institute (NCI)|