NCT06293066

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

February 27, 2024

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

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

    The need for further investigation

    Review of patients who attended clinic in 2022

Interventions

UltrasoundDIAGNOSTIC_TEST

Usefulness of transvaginal ultrasound

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with postmenopausal bleeding referred to the gynaecology rapid access clinic

You may qualify if:

  • 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
  • years of age or older
  • Ethnicity documented in their clinical notes

You may not qualify if:

  • Ethnicity data not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suite 8, King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 5, 2024

Study Start

January 31, 2024

Primary Completion

July 1, 2024

Study Completion

July 15, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations