Clinical trial · Observational
The Feasibility Study of the Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period
The Feasibility Study of Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period
- 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)
Investigators aim to collect endometrial sampling with Li Brush among target population who have risks for endometrial neoplasm, then Fractional curettage should performed with these participants, investigators intend to compare the pathological diagnosis results of cytology and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect that the brush can be used for screening of endometrial cancer in the postmenopausal period in the clinic.
Conditions
Conditions (1)
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 Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- endometrial neoplasms
- description
- patients with risk of endometrial cancer in the postmenopausal period
Primary outcomes (1)
- measure
- Compare the new diagnosis method with gold standard via Kappa statistic
- timeFrame
- one week within the enrollment
- description
- Kappa statistic will be used to access the agreement of the two diagnosis results. The diagnosis result is dichotomous data: having endometrial cancer or not. The safety risk is the same as it of the gold standard.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Postmenopausal abnormal uterine bleeding; 2. Ultrasound of the pelvic showed thickened endometrial ( usually more than 5mm) ; 3. Family history of endometrial cancers; 4. Other participants with risks for endometrial cancer (such as fat, Lynch Syndrome and so on) Exclusion Criteria: 1. Cervical cancer; 2. Fever (body's temperature is higher than 37.5 degrees ); 3. Vaginitis (excluding atrophic vaginitis); 4. Patients who cannot bear the operation; 5. Coagulation disorders; 6. Pregnancy and suspected pregnancy.
References
Publications (4)
- BACKGROUNDMeads C, Sutton A, Malysiak S, Kowalska M, Zapalska A, Rogozinska E, Baldwin P, Rosenthal A, Ganesan R, Borowiack E, Barton P, Roberts T, Sundar S, Khan K. Sentinel lymph node status in vulval cancer: systematic reviews of test accuracy and decision-analytic model-based economic evaluation. Health Technol Assess. 2013 Dec;17(60):1-216. doi: 10.3310/hta17600. PMID 24331128
- BACKGROUNDDemirkiran F, Yavuz E, Erenel H, Bese T, Arvas M, Sanioglu C. Which is the best technique for endometrial sampling? Aspiration (pipelle) versus dilatation and curettage (D&C). Arch Gynecol Obstet. 2012 Nov;286(5):1277-82. doi: 10.1007/s00404-012-2438-8. Epub 2012 Jul 6. PMID 22766754
- BACKGROUNDKipp BR, Medeiros F, Campion MB, Distad TJ, Peterson LM, Keeney GL, Halling KC, Clayton AC. Direct uterine sampling with the Tao brush sampler using a liquid-based preparation method for the detection of endometrial cancer and atypical hyperplasia: a feasibility study. Cancer. 2008 Aug 25;114(4):228-35. doi: 10.1002/cncr.23636. PMID 18548528
- BACKGROUNDWilliams AR, Brechin S, Porter AJ, Warner P, Critchley HO. Factors affecting adequacy of Pipelle and Tao Brush endometrial sampling. BJOG. 2008 Jul;115(8):1028-36. doi: 10.1111/j.1471-0528.2008.01773.x. PMID 18651884