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Assessment of Screening Modalities for Gynecologic Cancers

50 Years
Open (Enrolling)
Ovarian Cancer, Endometrial Cancer

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Trial Information

Assessment of Screening Modalities for Gynecologic Cancers


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


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.

Inclusion Criteria


- The study will enroll a total of 170 women consented for hysterectomy. One hundred
and seventeen (117) will either have 1) suspected ovarian cancer based on clinical
impression, cytologic or histologic diagnoses (effusions, Pap tests or other
biopsies), or 2) suspected endometrial cancer based on biopsy diagnoses of atypical
endometrial hyperplasia (or its equivalent endometrial intraepithelial neoplasia),
endometrial intraepithelial carcinoma (i.e. in-situ/ early serous carcinoma) or
carcinoma. Fifty-three (53) will be undergoing definitive treatment for benign
conditions (uterine fibroids, benign appearing adnexal pathology and normal CA 125,
pelvic floor dysfunction not to exceed grade 1 or 2 uterine descensus). Since the
analyzed cancers do not occur in children, they will not be included in this study.


- Surgical candidates for recurrent disease

- Preoperative neoadjuvant chemotherapy or radiotherapy

- History of tubal ligation, salpingitis, or hysterectomy (ovarian cancer patients)

- Control patients who are less than 45 years of age.

- Patients receiving treatment for active endometriosis.

- Cervical stenosis recognized clinically by not accepting the Tao Brush

- Endometrial sampling within 5 days of anticipated surgery

- Prior history of endometrial ablation

- Patients with cervical cancer

Type of Study:


Study Design:

Time Perspective: Retrospective

Principal Investigator

Nicolas Wentzensen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

April 2009

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Endometrial Cancer
  • Screening
  • Modalities
  • Gynecological Cancers
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Adenoma



Mayo Clinic, Rochester Rochester, Minnesota  55905