Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer

NCT ID: NCT04995731

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 328 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-07-31

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.

Conditions

Endometrial Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Women with pre or peri-menopausal abnormal uterine bleeding or post menopausal bleeding

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.

Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH)

Intervention Type: BEHAVIORAL

Bleeding type, age, race, parity, early menarche or late menopause, body mass index, body composition, hypertension, type II diabetes, anovulation, polycystic ovary syndrome and smoking history. Other epidemiologic risk factors including tamoxifen exposure, history of breast cancer, current hormone therapy use, anticoagulant use, oral contraception use, family history of endometrial, breast or colon cancer.

transvaginal ultrasound examination

Intervention Type: PROCEDURE

All patients will undergo a standard transvaginal ultrasound examination followed by power Doppler endometrial vascularity assessment. After ultrasound examination, all patients will undergo endometrial sampling either through hysteroscopy or dilatation and curettage operation (D, C) or will have histopathological evaluation of biopsy specimens obtained by hysterectomy. Histopathological evaluation will serve as a gold standard for the final diagnosis.

Interventions

Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH)

Bleeding type, age, race, parity, early menarche or late menopause, body mass index, body composition, hypertension, type II diabetes, anovulation, polycystic ovary syndrome and smoking history. Other epidemiologic risk factors including tamoxifen exposure, history of breast cancer, current hormone therapy use, anticoagulant use, oral contraception use, family history of endometrial, breast or colon cancer.

Intervention Type: BEHAVIORAL

transvaginal ultrasound examination

All patients will undergo a standard transvaginal ultrasound examination followed by power Doppler endometrial vascularity assessment. After ultrasound examination, all patients will undergo endometrial sampling either through hysteroscopy or dilatation and curettage operation (D, C) or will have histopathological evaluation of biopsy specimens obtained by hysterectomy. Histopathological evaluation will serve as a gold standard for the final diagnosis.

Intervention Type: PROCEDURE

Other Intervention Names

power Doppler endometrial vascularity assessment; endometrial sampling

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Norhan Tarek Sayed

assistant lecturer of obstetrics and gynecology, Faculty of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Norhan T Sayed, Masters

Role: CONTACT

norhantareq@yahoo.com

+201032747426

Facility Contacts

Norhan T Sayed, Masters

Role: primary

norhantareq@yahoo.com

01032747426

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Burbos N, Musonda P, Duncan TJ, Crocker SG, Morris EP, Nieto JJ. Estimating the risk of endometrial cancer in symptomatic postmenopausal women: a novel clinical prediction model based on patients' characteristics. Int J Gynecol Cancer. 2011 Apr;21(3):500-6. doi: 10.1097/IGC.0b013e31820c4cd6.

Reference Type: BACKGROUND

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Other Identifiers

AssiutNT

Identifier Type: -

Identifier Source: org_study_id