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

NCT ID: NCT06293066

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-07-15

Brief Summary

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Primary Objective:

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

Detailed Description

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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 hormone replacement therapy (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.

Conditions

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Postmenopausal Bleeding Endometrial Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Ultrasound

Usefulness of transvaginal ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Women seen in the 'two-week wait' rapid access Gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022

* 45 years of age or older
* Ethnicity documented in their clinical notes

Exclusion Criteria

* Ethnicity data not available
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Suite 8, King's College Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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KCH23-257

Identifier Type: -

Identifier Source: org_study_id

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