Status:
COMPLETED
Assessment of Screening Modalities for Gynecologic Cancers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Endometrial Cancer
Eligibility:
FEMALE
50-120 years
Brief 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...
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 cytologica...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 9 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 16 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00879840
Start Date
April 9 2009
End Date
November 16 2020
Last Update
November 17 2020
Active Locations (1)
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1
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905