Assessment of Screening Modalities for Gynecologic Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00879840
First received: April 10, 2009
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

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.

Condition
Ovarian Cancer
Endometrial Cancer

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Assessment of Screening Modalities for Gynecologic Cancers

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 170
Study Start Date: April 2009
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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.

EXCLUSION CRITERIA:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879840

Contacts
Contact: Patricia Madigan (301) 435-3974 madiganp@mail.nih.gov
Contact: Nicolas Wentzensen, M.D. (301) 435-3975 wentzenn@mail.nih.gov

Locations
United States, Minnesota
Mayo Clinic, Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Nicolas Wentzensen, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00879840     History of Changes
Other Study ID Numbers: 999909121, 09-C-N121
Study First Received: April 10, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Screening
Modalities
Gynecological Cancers

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 28, 2014