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Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer

NCT04995731 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 328

Last updated 2022-08-03

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-07-31
Completion
2024-07-31

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04995731 on ClinicalTrials.gov