Clinical trial · Observational
Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Screening and Fertility-Preservation Evaluation
A Prospective, Open, Observational Clinical Study on Endometrial Cytology and Cervical Methylation Testing for Screening and Evaluating Fertility-Sparing Treatment in 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)
The current study aims to assess high-risk patients using both liquid-based cytology and cervical methylation testing. The results will be compared with the traditional hysteroscopic pathological findings to determine the sensitivity and specificity of these methods for early detection of endometrial cancer, thereby evaluating their potential application in early screening. Primary Objectives： 1. To evaluate the sensitivity, specificity, and accuracy of endometrial cytology for screening endometrial cancer. 2. To assess the sensitivity, specificity, and accuracy of methylation testing for screening endometrial cancer. 3. To perform further molecular testing on tissue samples obtained from endometrial cytology and cervical methylation tests, aiming to explore early screening-sensitive indicators. Secondary Objectives： 1. To determine the value of endometrial cytology in evaluating the efficacy of fertility-sparing treatments for endometrial cancer. 2. To assess the value of methylation testing in evaluating the efficacy of fertility-sparing treatments for endometrial cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytology | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fertility Preservation | — | UNRESOLVED | — |
| Liquid Biopsy | — | UNRESOLVED | — |
| Methylation | — | UNRESOLVED | — |
| Non-invasive | — | UNRESOLVED | — |
| Screening Tool | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical Methylation Testing | Diagnostic Test | — | UNRESOLVED |
| Endometrial Cytology Testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- comparing to the traditional hysteroscopic pathological findings to determine the sensitivity and specificity of Endometrial Cytology and Cervical Methylation Testing
- timeFrame
- From enrollment to the end of treatment at 1 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Participants must meet all of the following criteria to be eligible for the study: 1. Color Doppler ultrasound indicating intrauterine masses or abnormal endometrial thickening (for postmenopausal women not receiving hormone replacement therapy, endometrial thickness \>5mm). 2. Patients undergoing follow-up and efficacy evaluation for fertility-sparing treatment of endometrial cancer or atypical endometrial hyperplasia. 3. Patients with endometrial thickening following endocrine therapy for breast cancer. 4. Signed informed consent form. 5. Good compliance. Exclusion Criteria: * Participants meeting any of the following criteria will be excluded: 1. Diagnosed with cervical cancer. 2. Severe systemic complications preventing hysteroscopy. 3. Pregnant or recent history of miscarriage. 4. Acute genital tract infection or pelvic inflammatory disease. 5. Insertion of an intrauterine device. 6. Sexual activity, vaginal douching, or medication use within 24 hours.
References
Publications (17)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDSakna NA, Elgendi M, Salama MH, Zeinhom A, Labib S, Nabhan AF. Diagnostic accuracy of endometrial sampling tests for detecting endometrial cancer: a systematic review and meta-analysis. BMJ Open. 2023 Jun 23;13(6):e072124. doi: 10.1136/bmjopen-2023-072124. PMID 37355271
- BACKGROUNDBarrett JE, Jones A, Evans I, Herzog C, Reisel D, Olaitan A, Mould T, MacDonald N, Doufekas K, Newton C, Crosbie EJ, Bjorge L, Colombo N, Dostalek L, Costas L, Peremiquel-Trillas P, Ponce J, Matias-Guiu X, Zikan M, Cibula D, Wang J, Sundstrom K, Dillner J, Widschwendter M. The WID-EC test for the detection and risk prediction of endometrial cancer. Int J Cancer. 2023 May 1;152(9):1977-1988. doi: 10.1002/ijc.34406. Epub 2023 Jan 17. PMID 36533702
- BACKGROUNDHerzog C, Marin F, Jones A, Evans I, Reisel D, Redl E, Schreiberhuber L, Paytubi S, Pelegrina B, Carmona A, Peremiquel-Trillas P, Frias-Gomez J, Pineda M, Brunet J, Ponce J, Matias-Guiu X, de Sanjose S, Alemany L, Olaitan A, Wong M, Jurkovic D, Crosbie EJ, Rosenthal AN, Bjorge L, Zikan M, Dostalek L, Cibula D, Sundstrom K, Dillner J, Costas L, Widschwendter M. A Simple Cervicovaginal Epigenetic Test for Screening and Rapid Triage of Women With Suspected Endometrial Cancer: Validation in Several Cohort and Case/Control Sets. J Clin Oncol. 2022 Nov 20;40(33):3828-3838. doi: 10.1200/JCO.22.00266. Epub 2022 Aug 24. PMID 36001862
- BACKGROUNDWeimer J, Huttmann M, Nusilati A, Andreas S, Roseler J, Tribian N, Rogmans C, Stope MB, Dahl E, Mustea A, Stickeler E, Hedemann N, Florkemeier I, Tiemann K, Magadeeva S, Dempfle A, Arnold N, Maass N, Bauerschlag D. Fluorescence in situ hybridization test for detection of endometrial carcinoma cells by non-invasive vaginal swab. J Cell Mol Med. 2023 Feb;27(3):379-391. doi: 10.1111/jcmm.17658. Epub 2023 Jan 10.