Clinical trial · Observational
Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples
Methylation Markers for Natural History and Early Detection of Endometrial Cancer
- 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 cancer is one of the most common gynecologic cancers. If it is caught at an early stage, it can be treated more easily. Women who have this type of cancer often have a history of irregular menstrual bleeding. They may also have abnormal findings during gynecologic exams. Pap smears and cervical cell collection may be able to collect cell samples for cancer testing. However, samples from the vagina or endometrium may produce more accurate results. Researchers want to collect vaginal and endometrial cell samples to improve their tests for and understanding of endometrial cancer. Objectives: \- To collect vaginal and endometrial cell samples to study endometrial cancer. Eligibility: \- Women at least 18 years of age who have had symptoms of abnormal uterine or post-menopausal bleeding, or abnormal ultrasound findings. Design: * Participants will be screened with a physical exam and medical history. * Participants will have a pelvic exam. Before the exam, they will insert a small tampon in the vagina. The tampon will stay in place for about 10 to 30 minutes. The tampon will then be removed and collected for the study. * During the pelvic exam, tissue will be collected from the uterine lining with a special brush. An additional sample (biopsy) will be collected from the lining. * A blood sample will also be collected as part of the study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecological Cancers | Endometrial Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Endometrial Cancer Cohort
- description
- Women with abnormal bleeding or other conditions associated with increased risk ofendometrial cancer.
Primary outcomes (1)
- measure
- Endometrial Cancer and Endometrial Hyper Plasia
- timeFrame
- 1 to 5 years
- description
- Histologically confirmed endometrial cancer or endometrial hyperplasia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 120 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Women should meet at least one of the following criteria: * Abnormal uterine bleeding * Postmenopausal bleeding * Thickened endometrial stripe * Hereditary predisposition to endometrial cancer (e.g. HNPCC) * Women referred for endometrial biopsy to evaluate suspicion or high risk of endometrial cancer EXCLUSION CRITERIA: * Prior hysterectomy * Pregnant women (There will be a verbal screen by the clinic nurse and the physician about a potential pregnancy and a pregnancy test may be conducted if there is any doubt) * Prior pelvic radiation * Cervical stenosis that renders Tao brush sampling impossible
References
Publications (3)
- BACKGROUNDArmstrong K, Randall TC, Polsky D, Moye E, Silber JH. Racial differences in surgeons and hospitals for endometrial cancer treatment. Med Care. 2011 Feb;49(2):207-14. doi: 10.1097/MLR.0b013e3182019123. PMID 21150796
- BACKGROUNDDimitraki M, Tsikouras P, Bouchlariotou S, Dafopoulos A, Liberis V, Maroulis G, Teichmann AT. Clinical evaluation of women with PMB. Is it always necessary an endometrial biopsy to be performed? A review of the literature. Arch Gynecol Obstet. 2011 Feb;283(2):261-6. doi: 10.1007/s00404-010-1601-3. Epub 2010 Aug 4. PMID 20683604
- BACKGROUNDLacey JV Jr, Ioffe OB, Ronnett BM, Rush BB, Richesson DA, Chatterjee N, Langholz B, Glass AG, Sherman ME. Endometrial carcinoma risk among women diagnosed with endometrial hyperplasia: the 34-year experience in a large health plan. Br J Cancer. 2008 Jan 15;98(1):45-53. doi: 10.1038/sj.bjc.6604102. Epub 2007 Nov 20. PMID 18026193