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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06293066
• Other study ID #: KCH23-257
• Status: Active, not recruiting
• Start date: January 31, 2024
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2024
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Hemorrhage
• Postmenopausal Bleeding
• Uterine Hemorrhage

Intervention

Diagnostic Test:
• Ultrasound
Usefulness of transvaginal ultrasound

Locations

Country	Name	City	State
United Kingdom	Suite 8, King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether there is a higher incidence of uninformative ultrasound in black vs white women		Review of patients who attended clinic in 2022