Endometrial CancerNCT04995731
Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer
An observational study of Endometrial Cancer, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH) and transvaginal ultrasound examination
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 328 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Norhan T Sayed, Masters, 01032747426, norhantareq@yahoo.com
About this study
Official title: Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer: Development and Validation of Clinical-ultrasound Based Scoring System(A Cross Sectional -Validation Study)
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.
Read the 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
- Being tested
- Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH), transvaginal ultrasound examination
- Keywords
- endometrial hyperplasia
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH)Behavioural
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 examinationProcedure or surgery
Also called power Doppler endometrial vascularity assessment, endometrial sampling
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH); Procedure: transvaginal ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of endometrial cancer, endometrial hyperplasia
Magnitude and prevalence of endometrial cancer, endometrial hyperplasia using a practical clinical-ultrasound based scoring system.
Measured: 3 years
Secondary outcomes (1)
prevalence of endometrial benign lesions
calculate absolute risks (prevalent risk) of endometrial benign lesions.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Sep 2021
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Tarek Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995731
- Sponsor's protocol ID
- AssiutNT
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30083701Matteson 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.
PubMed 30083765Pennant 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.
PubMed 27766759Du 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.
PubMed 27515060Szubert 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.
PubMed 31782548Gull 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.
PubMed 12592247Dueholm 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.
PubMed 27818130Dueholm 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.
PubMed 31027672Burbos 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.
PubMed 21436697
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer: Development and Validation of Clinical-ultrasound Based Scoring System(A Cross Sectional -Validation Study)
- ClinicalTrials.gov ID
- NCT04995731
- Acronym / sponsor ID
- AssiutNT
- Conditions
- Endometrial Cancer
- Keywords
- endometrial hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with pre or peri-menopausal abnormal uterine bleeding or post menopausal bleeding | – | Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH), Procedure: transvaginal ultrasound examinationEligible 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Women with pre or peri-menopausal abnormal uterine bleeding or post menopausal bleeding |
| transvaginal ultrasound examinationAlso: power Doppler endometrial vascularity assessment, endometrial samplingAll 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. | Procedure or surgery | Women with pre or peri-menopausal abnormal uterine bleeding or post menopausal bleeding |
Primary outcome
prevalence of endometrial cancer, endometrial hyperplasia
Time frame: 3 years
Magnitude and prevalence of endometrial cancer, endometrial hyperplasia using a practical clinical-ultrasound based scoring system.
1 secondary outcome
prevalence of endometrial benign lesions
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 30083701Clarke 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.
- Background: PubMed 30083765Matteson 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.
- Background: PubMed 27766759Pennant 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.
- Background: PubMed 27515060Du 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.
- Background: PubMed 31782548Szubert 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.
- Background: PubMed 12592247Gull 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.
- Background: PubMed 27818130Dueholm 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.
- Background: PubMed 31027672Dueholm 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.
- Background: PubMed 21436697Burbos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norhan T Sayed, Masters (+201032747426, norhantareq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of endometrial cancer, endometrial hyperplasia (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04995731, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.