Assessment of Screening Modalities for Gynecologic Cancers

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 08-008184
    NCT ID: NCT00879840
    Sponsor Protocol Number: 08-008184

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Contact us for the latest status

Contact information:

Marla Kay Sommerfield

(507)266-3053

Sommerfield.Marla-Kay@mayo.edu

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CLS-20151612

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