Clinical trial · Observational
Assessment of Screening Modalities for Gynecologic Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Controls Without Endometrial Cancer | — | UNRESOLVED | — |
| Controls Without Ovarian Cancer | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Females
- description
- With endometrial cancer, ovarian cancer, and women undergoing hysterectomy for benign reasons.
Primary outcomes (1)
- measure
- Endometrial Cancer, ovarian cancer
- timeFrame
- 1 year
- description
- Histologically confirmed endometrial or ovarian cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 120 Years
Show eligibility criteria text
* 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
References
Publications (3)
- BACKGROUNDRies LA. Ovarian cancer. Survival and treatment differences by age. Cancer. 1993 Jan 15;71(2 Suppl):524-9. doi: 10.1002/cncr.2820710206. PMID 8420672
- BACKGROUNDBuys SS, Partridge E, Greene MH, Prorok PC, Reding D, Riley TL, Hartge P, Fagerstrom RM, Ragard LR, Chia D, Izmirlian G, Fouad M, Johnson CC, Gohagan JK; PLCO Project Team. Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of a randomized trial. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9. doi: 10.1016/j.ajog.2005.05.005. PMID 16260202
- BACKGROUNDVine MF, Ness RB, Calingaert B, Schildkraut JM, Berchuck A. Types and duration of symptoms prior to diagnosis of invasive or borderline ovarian tumor. Gynecol Oncol. 2001 Dec;83(3):466-71. doi: 10.1006/gyno.2001.6411. PMID 11733956