Clinical trial NCT04995731: Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer
Official title: Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer: Development and Validation of Clinical-ultrasound Based Scoring System(A Cross Sectional -Validation Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Keywords: endometrial hyperplasia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 328
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible women presenting to Women's Health hospital with pre or peri-menopausal abnormal uterine bleeding(AUB )or Postmenopausal (PMB)will be prospectively enrolled after obtaining their informed consent. Abnormal uterine bleeding 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.

Brief summary: 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.

Detailed description: Approximately 90% of endometrial cancer (EC) cases are preceded by AUB in premenopausal or perimenopausal women or post-menopausal bleeding (PMB).Transvaginal ultrasonography(TVS) has become the first step diagnostic tool of AUB. The main advantage of ultrasound imaging is that it has high accuracy for the preoperative classiﬁcation of intra and extra uterine lesions, both benign and malignant. If increased endometrial thickness (ET) is found in women with PMB, the risk of EC increases. However, in women with type II EC, ET below 3-4 mm might also be found. Because of these limitations, ET should not be the only factor for cancer risk estimation in women with AUB.

Three-dimensional sonography and blood ﬂow vascular indices improve the diagnostic precision of the sonographic estimation of endometrial lesions. Several scoring systems using different ultrasound image characteristics were proposed to estimate the risk of EC in women with AUB including the recently proposed system" Risk of Endometrial Cancer scoring model "(REC).

Existing guidelines recommend considering clinical risk factors such as BMI, age, obesity, type II diabetes, polycystic ovary syndrome(PCOS) and use of unopposed estrogen when evaluating AUB. However, only few clinical risk prediction models have been developed.

Despite the important role of ultrasound imaging in assessment of endometrial lesions, one wonders if clinical variables can improve the diagnostic performance of risk prediction models.

The aim of the study is to create a risk-scoring model of endometrial hyperplasia and endometrial cancer using patient clinical characteristics and ultrasound image characteristics among women with abnormal uterine bleeding, and to validate the diagnostic performance of our model and to compare it's predictive value with the recently proposed REC score for EC risk stratiﬁcation.

Eligibility criteria: 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.

Primary outcomes:
measure: prevalence of endometrial cancer, endometrial hyperplasia
timeFrame: 3 years
Secondary outcomes:
measure: prevalence of endometrial benign lesions
timeFrame: 3 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Clarke 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.
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