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

K

King's College Hospital NHS Trust

Status

Active, not recruiting

Conditions

Endometrial Cancer
Postmenopausal Bleeding

Treatments

Diagnostic Test: Ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT06293066
KCH23-257

Details and patient eligibility

About

Primary Objective:

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

Full description

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.

Enrollment

330 patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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