Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Hemorrhage

Uterine Hemorrhage

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ultrasound

Primary Objective:

To assess whether there is a higher incidence of uninformative ultrasound in black vs white women

Retrospective cohort study

Study Subjects:

Women 45 years or over seen in the 'two-week wait' rapid access Gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022. Only people with documented ethnicity will be included.

Study Procedures:

Cases will be identified by searching our two-week referral and ultrasound records . Clinical data collected includes age, BMI, previous abdominal uterine surgery (Caesarean section or open myomectomy) and parity. Symptoms will be categorised into postmenopausal bleeding with no hormone use, unscheduled bleeding on HRT or abnormal perimenopausal bleeding (in women over 45 years of age).

Ultrasound data recorded will be the presence or absence of fibroids, whether transabdominal ultrasound was needed in addition to transvaginal or transrectal ultrasound, whether the endometrium could be seen clearly (i.e whether the ultrasound examination was informative) and the endometrial thickness in those where it was. Clinical outcomes recorded will be the need for endometrial sampling, mode of sampling and histology results. The local cancer registry will be checked for the year following the study to check for any subsequent cancers in women discharged without endometrial sampling.

Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study.

King's College Hospital NHS Trust

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Patients attending a gynaecology clinic for investigation of postmenopausal bleeding and undergoing a transvaginal ultrasound (TVUS).

ADXGYNAE is a non-invasive ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the detection of endometrial cancer in women with postmenopausal bleeding who are suspected of having endometrial cancer. Participants will be asked to provide a urine specimen, which will be centrifuged before the sediment is lysed. The lysed sample will then be tested with the MCM5 ELISA.

MCM5 ELISA

Jacqueline Stockley, PhD

Prof Richard Edmondson

Professor Richard Edmondson, MD

The objective of this multi-centre, prospective study, is to evaluate the performance of a urine MCM5 ELISA test (ADXGYNAE) in the detection of endometrial cancer in patients with postmenopausal bleeding. Patients attending a gynaecology clinic for investigation of postmenopausal bleeding will be recruited and asked to provide a urine sample to be tested. The results of the MCM5 test will be recorded and compared to the patient's routine investigations to determine the clinical utility of the test as an aid in the diagnosis of endometrial cancer.

Evaluation of MCM5 in Postmenopausal Bleeding Patients

A Performance Evaluation Study of Arquer Diagnostics Ltd's MCM5 ELISA (ADXGYNAE) Test to Aid in the Diagnosis of Endometrial Cancer

The MCM5 test result will be compared with data obtained from patient's standard of care clinical investigations, including results from transvaginal ultrasound (TVUS) and endometrial biopsy or hysteroscopy. A definitive diagnosis of endometrial cancer will be confirmed by the presence of histologically proven endometrial cancer on resection/biopsy. Patients who do not have an endometrial biopsy will be followed up at 6 months to identify if further investigations were carried out.

Arquer Diagnostics Ltd

100 women with postmenopausal bleeding undergoing 2D greyscale vaginal ultrasound and 3D Endometrial power Doppler and the features were classified using six different vascular patterns described by IETA group including the following patterns; single dominant vessel without branching, with branching, multiple vessels with focal origin, with multifocal origin at the myometrium-endometrium junction, scattered vessels or circular flow (Kucur et al., 2013 ).

All patients then had Office hysteroscopy carried out in the outpatient clinic using vaginoscopic approach (Cooper et al., 2010). With endometrial samples from lesions or from the cavity for histopathological analysis.

To assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform).

2D grey scale vaginal ultrasound

To assess the endometrium using the IETA group criteria.

3D power Doppler vaginal ultrasound

using the vaginoscopic approach to assess the uterine cavity and take sample.

Office hysteroscopy

100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D power Doppler ultrasound using the international endometrial tumor analysis group and office hysteroscopy with taking samples for histopathological analysis.

The aim was to compare the efficiency of the upper mentioned interventions in diagnosing the cause of postmenopausal bleeding.

Sample from the uterine endometrium for histopathological analysis

Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding

The Role of Office Hysteroscopy and Endometrial Power Doppler Using the International Endometrial Tumor Analysis Group Classification in the Evaluation of Postmenopausal Bleeding

Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding

Cairo University

Wen Ying Fung

Endometrial cancer is the most common malignancy of the female genital tract in Hong Kong. The aim in the evaluation of PMB is to exclude underlying malignancy. Endometrial thickness (ET) measured by transvaginal ultrasound scanning (TVS) and endometrial biopsy or sampling (ES) has been recommended as the first-line investigation. From a study between 2002-2013 in the One-stop PMB clinic, investigators found that ET was able to identify women with endometrial cancer with the sensitivity at 3mm, 4mm, and 5mm, the current levels recommended in professional guidelines, being 97.0%, 94.1%, and 93.5% respectively. However, little is known about the level of patient's acceptance of the false negative rate and how patient would trade residual risk with more invasive test. There is also a lack of study on the experience of women during the management pathway especially the level of anxiety before and after investigations and the pain experienced from the investigations offered. The current study aim to study the level of false negative rate accepted by women for the investigation of PMB and the level of anxiety and pain experienced during the investigation pathway.

Endometrial cancer is the most common malignancy of the female genital tract in Hong Kong. It is estimated that around 10% of women experience postmenopausal bleeding. Around 90% of women with endometrial cancer initially presented with postmenopausal bleeding (PMB). The aim in the evaluation of PMB is to exclude underlying malignancy. Clinical tests to evaluate the endometrium include transvaginal ultrasound scanning (TVS) to measure endometrial thickness (ET), endometrial biopsy or sampling (ES), saline infusion sonography, and hysteroscopy. TVS ET or ES has been recommended as the first-line investigation.

There are, however, different ET cut-off values recommended by various professional groups. From a study between 2002-2013 in the One-stop PMB clinic, investigators found that ET was able to identify women with endometrial cancer with the sensitivity at 3mm, 4mm, and 5mm, the current levels recommended in professional guidelines, being 97.0%, 94.1%, and 93.5% respectively.

Although clinical management guidelines and accuracy data are available, little is known about the level of patient's acceptance of the false negative rate and how patient would trade residual risk with more invasive test. There is also a lack of study on the experience of women during the management pathway especially the level of anxiety before and after investigations and the pain experience from the investigations offered. There is only one study identified from the literature which suggested high levels of anxiety in women who experienced PMB.

There is a dedicated Postmenopausal Bleeding Clinic for the one-stop evaluation for PMB in Hong Kong and investigators receive referrals from other centers in Hong Kong. It is a tertiary-care university institution with two affiliated hospitals.

All patients who are new referrals for the symptom of PMB will be invited to participate in the study. Informed consent form will be obtained from all patients participating in the study. Patients will be asked to read written information on postmenopausal bleeding including the risk of endometrial cancer and investigation options including TVS ET, hysteroscopy and ES. The information will be focused on the detection rate and procedure-related risk. The interviewer will specify that 1) hysteroscopy and ES will be considered to offer 100% detection rate but there is procedure related risks including pain, bleeding, infection, uterine perforation because entrance into the uterine cavity is required 2) TVS ET do not require entry into uterine cavity but the detection rate is not 100%. Then patients will undergo a structured interview by an interviewer using the standard gamble technique.

In the standard gamble test, patients will be asked to choose from a guaranteed outcome (e.g. being blind for the rest of their life), or whether patients would prefer an alternative state with some chance of a worst outcome (e.g. dying, "1-p") and a complementary chance of an ideal outcome (e.g. continue to live healthily, "p"). The risks of the two situations will be varied until the patient is unable to decide either of the two options. This allows quantitative comparison of the health states, which allow us to understand the decision -making process of the patient. The interviewer will use blindness, death and healthy life to ensure the patient understand the standard gamble method. The participant will be asked to make a decision starting with a probability of 100%, which will then be reduced in steps of 10% until it reach 10% after which it will be decreased at 1% interval until 2% and thereafter at 0.1% interval, until the participant is not unable to make a choice between the two options.

Then the exercise will be repeated to test the preferences towards the investigations for PMB. The patient will be asked to choose between one of the tests (1) TVS ET (2) hysteroscopy with ES. In order to determine the level of acceptance of false negative rate using TVS ET, the assumed detection rate of the test will be quoted as 75% and increase in steps in 5% interval until it reach 90%, then increase at 1% interval until it reach 98%, and then at 0.1% interval until it reach 99.9%.

The anxiety level will be assessed by the Full form State-Anxiety scale. Since anxiety may be affected by the anticipated pain associated with each investigation. Patient's idea about the potential pain which will experience from the different investigations (TVS ET, hysteroscopy, ES) will be rated by a visual analogue scale from 0-10.

The patient will then enter the consultation room and have the PMB assessment. After the consultation, the patient will be interviewed again. The standard gamble and anxiety level will be assessed again to determine if the actual experience after the PMB assessments changed the patients' choice. The actual VAS score on the investigations received will be recorded. The patient will then be asked to complete the same anxiety questionnaire 3 months from the consultation and return by the return envelops provided.

Patient's Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding

The level of acceptance of false negative rate using endometrial thickness assessed by transvaginal ultrasound scanning to identify endometrial cancer.

Chinese University of Hong Kong

Associate Consultant

Carcinoma

Hyperplasia

Endometrial Hyperplasia

Disease Progression

Women in one large U.S. health care plan. Cases will consist of women who developed endometrial carcinoma or censored complex atypical hyperplasia at least 1 year after receiving a diagnosis of endometrial hyperplasia.

Women in one large U.S. health care plan. Controls will consist of individually matched women who received a diagnosis of endometrial hyperplasia at the same age and date as the cases and were cancer-free and hysterectomy-free until the date at which the index cases were diagnosed with endometrial carcinoma or censored complex atypical hyperplasia.

Nicolas Wentzensen, M.D.

This study, conducted jointly by the National Cancer Institute and the Kaiser Permanente Center for Health Research Northwest (KPCHRN) in Portland, Oregon, will lay the groundwork for a future study to identify precursors of endometrial cancer; that is, conditions that precede development of cancer of the lining of the uterus. The diagnosis of endometrial hyperplasia (a condition of abnormal proliferation of endometrial tissue) includes most precursors of endometrial cancer, as well as many benign conditions. Currently, three methods of classifying endometrial cancer precursors have been suggested based on endometrial hyperplasia findings, but it is not known which classification best predicts cancer risk.

This study will examine surgical specimens of hyperplasia and cancer from women diagnosed with endometrial cancer at least 2 years after a diagnosis of endometrial hyperplasia. Investigators will estimate the percentage of cases with different degrees of hyperplasia, and assess the subsequent cancers that developed. This will allow them to rank hyperplasia lesions according to cancer risk and identify lesions that represent the most immediate cancer precursors. They will also review patients medical charts for information related to cancer risk and treatment.

Study participants will include women enrolled in the KPCHRN who are 40 years of age or older and who were diagnosed with endometrial cancer at least 2 years after being diagnosed with endometrial hyperplasia.

Three systems have been proposed to classify endometrial carcinoma precursors, but it is currently unclear which system best predicts cancer risk and is most reproducible. The optimal surrogate endpoint for endometrial carcinoma is therefore unknown. The pathologic diagnosis of endometrial hyperplasia (EH) includes most suspected immediate precursors and many mild, highly reversible proliferations. We propose an exploratory study to assess the feasibility of investigating EH as a source of an endometrial carcinoma surrogate endpoint.

We are conducting a nested case-control study within a large, population-based health care plan. We will identify cases, defined as women who were diagnosed with EH at least one year before being diagnosed with endometrial carcinoma or severe atypical hyperplasia at hysterectomy, through a computerized search of plan databases. We will retrieve the slides from the matching biopsy and hysterectomy on which carcinoma was diagnosed. Women ages 40 or older who were plan members and received a biopsy or curettage diagnosis of EH between 1970 and 2002 will be eligible to be a case.

We will perform an initial histologic review of cases index biopsy slides to assess two types of misclassification known to affect the diagnosis of EH: a) false-negative endometrial carcinoma (i.e., prevalent carcinoma t the time of EH diagnosis) and b) false-positive EH (i.e., a benign, non-hyperplastic lesion). From cases physical records and linked computer records, we will collect data on histopathologic classification of EH lesions and subsequent carcinomas; descriptive data (e.g., patient weight, parity, and menopausal status); and a summary of relevant treatments and follow-up procedures (e.g., hormone therapy or additional clinical procedures).

We will select controls, defined as women who were diagnosed with EH but then did not develop endometrial carcinoma or undergo hysterectomy for a follow-up interval that is equivalent to the follow-up interval of the cases. Controls will be individually matched to cases on age at EH diagnosis, date of EH diagnosis, and duration of follow-up, and also counter-matched based on the original EH diagnosis. After selecting 3 controls per case, we will assemble the same data from controls: histologic review of original slides, descriptive data from medical records databases, and treatment and follow-up procedure data from linked databases.

These data will then be used to estimate the cancer risk associated with specific EH classifications, identify other patient or clinical factors that might modify those risks, explore predictors of EH, and explore molecular factors that might influence the probability of developing carcinoma after a diagnosis of EH.

Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer

Preliminary Study of Endometrial Hyperplasia: Groundwork for a Study to Define an Optimal Classification of Endometrial Carcinoma Precursors

Formalin fixed paraffin embedded tissue blocks and pathology slides from women with endometrial cancer and women with endometrial hyperplasia with covariate data from medical records.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study.	NCT06293066	Postmenopausal ... Endometrial Can...	Ultrasound	45 Years -	King's College Hospital NHS Trust
Evaluation of MCM5 in Postmenopausal Bleeding Patients	NCT05287048	Endometrial Can...	MCM5 ELISA	18 Years -	Arquer Diagnostics Ltd
Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding	NCT02488798	Postmenopausal ...	2D grey scale v... 3D power Dopple... Office hysteros...	47 Years - 64 Years	Cairo University
Patient's Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding	NCT03330015	Endometrial Can... Postmenopausal ...		40 Years - 69 Years	Chinese University of Hong Kong
Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding	NCT02488798	Postmenopausal ...	2D grey scale v... 3D power Dopple... Office hysteros...	47 Years - 64 Years	Cairo University
Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer	NCT00339651	Endometrial Hyp... Endometrial Can... Postmenopausal ... Vaginal Bleedin...		40 Years - 120 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for postmenopausal bleeding