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Assessment of Screening Modalities for Gynecologic Cancers

NCT00879840 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 118

Last updated 2020-11-17

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nicolas Wentzensen, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
50 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-09
Primary Completion
2020-09-02
Completion
2020-11-16

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00879840 on ClinicalTrials.gov