Clinical trial · Observational
Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer
Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer: Development and Validation of Clinical-ultrasound Based Scoring System(A Cross Sectional -Validation Study)
NCT04995731CI-TRIAL-00060082unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Abnormal uterine bleeding (AUB) represents common diagnostic challenge in everyday gynecological practice. However, abnormal bleeding is a common symptom of many benign diseases and only indicates the presence of EC in 9% of postmenopausal women and 1% to 2% of premenopausal women, suggesting that many women at low risk undergo unnecessary invasive procedures to rule out cancer. The aim of the study is to create a risk-scoring model of endometrial hyperplasia and endometrial cancer.
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 Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH) | Behavioral | — | UNRESOLVED |
| transvaginal ultrasound examination | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with pre or peri-menopausal abnormal uterine bleeding or post menopausal bleeding
- description
- Eligible women presenting to Women's Health hospital with pre or peri-menopausal AUB or PMB will be prospectively enrolled after obtaining their informed consent. AUB will be defined by symptoms of heavy menstrual bleeding, inter-menstrual bleeding, meno-metrorrhagia, irregular menses, or other AUB among women aged ≥40 years who are not in menopause. Peri-menopausal bleeding will be defined as vaginal bleeding after 6 months of menopause after the age of 40 years. Postmenopausal status will be defined as the absence of menstruation for at least 12 months after the age of 40 years, where any pathological condition of amenorrhea is excluded.
- interventionNames
- Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH)
- Procedure: transvaginal ultrasound examination
Primary outcomes (1)
- measure
- prevalence of endometrial cancer, endometrial hyperplasia
- timeFrame
- 3 years
- description
- Magnitude and prevalence of endometrial cancer, endometrial hyperplasia using a practical clinical-ultrasound based scoring system.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: women ≥40 years with pre- or perimenopausal AUB or PMB presenting to Women's Health Hospital, Department of Obstetrics and Gynecology, Faculty of medicine, Assiut University, Assiut, Egypt. Exclusion Criteria: * Women with a vaginal bleeding arising from a cervical, vaginal or vulvar disease. * Patients with cervical cancer or uterine metastases. * History of prior hysterectomy, prior pelvic radiation, endometrial sampling within the past 3 months. * Presence of existing pregnancy. * Women with inadequate endometrial sampling or with no histopathological diagnosis.
References
Publications (9)
- BACKGROUNDClarke MA, Long BJ, Del Mar Morillo A, Arbyn M, Bakkum-Gamez JN, Wentzensen N. Association of Endometrial Cancer Risk With Postmenopausal Bleeding in Women: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Sep 1;178(9):1210-1222. doi: 10.1001/jamainternmed.2018.2820. PMID 30083701
- BACKGROUNDMatteson KA, Robison K, Jacoby VL. Opportunities for Early Detection of Endometrial Cancer in Women With Postmenopausal Bleeding. JAMA Intern Med. 2018 Sep 1;178(9):1222-1223. doi: 10.1001/jamainternmed.2018.2819. No abstract available. PMID 30083765
- BACKGROUNDPennant ME, Mehta R, Moody P, Hackett G, Prentice A, Sharp SJ, Lakshman R. Premenopausal abnormal uterine bleeding and risk of endometrial cancer. BJOG. 2017 Feb;124(3):404-411. doi: 10.1111/1471-0528.14385. Epub 2016 Oct 20. PMID 27766759
- BACKGROUNDDu J, Li Y, Lv S, Wang Q, Sun C, Dong X, He M, Ulain Q, Yuan Y, Tuo X, Batchu N, Song Q, Li Q. Endometrial sampling devices for early diagnosis of endometrial lesions. J Cancer Res Clin Oncol. 2016 Dec;142(12):2515-2522. doi: 10.1007/s00432-016-2215-3. Epub 2016 Aug 11. PMID 27515060
- BACKGROUNDSzubert S, Szpurek D, Wojtowicz A, Zywica P, Stukan M, Sajdak S, Jablonski S, Wicherek L, Moszynski R. Performance of Selected Models for Predicting Malignancy in Ovarian Tumors in Relation to the Degree of Diagnostic Uncertainty by Subjective Assessment With Ultrasound. J Ultrasound Med. 2020 May;39(5):939-947. doi: 10.1002/jum.15178. Epub 2019 Nov 29. PMID 31782548
- BACKGROUNDGull B, Karlsson B, Milsom I, Granberg S. Can ultrasound replace dilation and curettage? A longitudinal evaluation of postmenopausal bleeding and transvaginal sonographic measurement of the endometrium as predictors of endometrial cancer. Am J Obstet Gynecol. 2003 Feb;188(2):401-8. doi: 10.1067/mob.2003.154. PMID 12592247
- Dueholm M, Hjorth IM. Structured imaging technique in the gynecologic office for the diagnosis of abnormal uterine bleeding. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:23-43. doi: 10.1016/j.bpobgyn.2016.09.010. Epub 2016 Oct 1.