Assessment of Screening Modalities for Gynecologic Cancers

Completed

Conditions studied: Ovarian Cancer, Endometrial Cancer, Controls Without Endometrial Cancer, Controls Without Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00879840

Run by

National Cancer Institute (NCI)

People needed

118

Starts

2009-04-09

Expected to finish

2020-11-16

Last updated by the study team

2020-11-17

Who can join

Age: 50 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic, Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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