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
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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ACTIVE_NOT_RECRUITING
330 participants
OBSERVATIONAL
2024-01-31
2024-07-15
Brief Summary
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To assess whether there is a higher incidence of uninformative ultrasound in black vs white women
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Detailed Description
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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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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Ultrasound
Usefulness of transvaginal ultrasound
Eligibility Criteria
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Inclusion Criteria
* 45 years of age or older
* Ethnicity documented in their clinical notes
Exclusion Criteria
45 Years
FEMALE
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Locations
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Suite 8, King's College Hospital
London, , United Kingdom
Countries
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Other Identifiers
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KCH23-257
Identifier Type: -
Identifier Source: org_study_id
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