Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer

NCT04995731 | Unknown

• 1 other identifier: AssiutNT
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

endometrial hyperplasia

Outcome Measures

Primary Outcomes (1)

• prevalence of endometrial cancer, endometrial hyperplasia

  Magnitude and prevalence of endometrial cancer, endometrial hyperplasia using a practical clinical-ultrasound based scoring system.

  3 years

Secondary Outcomes (1)

• prevalence of endometrial benign lesions

  3 years

Study Arms (1)

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.

Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH); Procedure: transvaginal ultrasound examination

Interventions

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

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

transvaginal ultrasound examination 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.

Also known as: power Doppler endometrial vascularity assessment, endometrial sampling

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

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 30083701 BACKGROUND

• Matteson 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 BACKGROUND

• Pennant 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 BACKGROUND

• Du 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 BACKGROUND

• Szubert 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 BACKGROUND

• Gull 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 BACKGROUND

• 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.

  PMID: 27818130 BACKGROUND

• Dueholm M, Hjorth IMD, Dahl K, Pedersen LK, Ortoft G. Identification of endometrial cancers and atypical hyperplasia: Development and validation of a simplified system for ultrasound scoring of endometrial pattern. Maturitas. 2019 May;123:15-24. doi: 10.1016/j.maturitas.2019.01.017. Epub 2019 Feb 1.

  PMID: 31027672 BACKGROUND

• 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.

  PMID: 21436697 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial sampling either through hysteroscopy or dilatation and curettage operation (D, C) or histopathological evaluation of biopsy specimens obtained by hysterectomy

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Norhan T Sayed, Masters

CONTACT

+201032747426; norhantareq@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of obstetrics and gynecology, Faculty of medicine

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: September 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)