Assessment of Screening Modalities for Gynecologic Cancers
Condition: Ovarian Cancer; Endometrial Cancer; Controls Without Endometrial Cancer; Controls Without Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Endometrial Neoplasms
Study type: Observational

Summary: 
      Background:

        -  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.

      Objectives:

        -  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.

      Eligibility:

        -  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.

      Design:

        -  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.
    

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.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with endometrial cancer, ovarian cancer, and women undergoing hysterectomy for benign
        reasons.
      
Keywords: Screening; Modalities; Gynecological Cancers