Postmenopausal BleedingNCT06293066
Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study.
An observational study of Postmenopausal Bleeding and Endometrial Cancer, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Primary Objective: To assess whether there is a higher incidence of uninformative ultrasound in black vs white women Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Postmenopausal Bleeding, Endometrial Cancer
- What is being tested?
- Ultrasound
- How many people
- 330 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2024to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with postmenopausal bleeding referred to the gynaecology rapid access clinic
Who may be able to join
- 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
Who cannot join
- Ethnicity data not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups
Primary Objective:
To assess whether there is a higher incidence of uninformative ultrasound in black vs white women
Read the detailed 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.
- Conditions
- Postmenopausal Bleeding, Endometrial Cancer
- Being tested
- Ultrasound
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Usefulness of transvaginal ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether there is a higher incidence of uninformative ultrasound in black vs white women
The need for further investigation
Measured: Review of patients who attended clinic in 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start31 Jan 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal BleedingStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293066
- Sponsor's protocol ID
- KCH23-257
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups
- ClinicalTrials.gov ID
- NCT06293066
- Acronym / sponsor ID
- KCH23-257
- Conditions
- Postmenopausal Bleeding, Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To assess whether there is a higher incidence of uninformative ultrasound in black vs white women
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with postmenopausal bleeding referred to the gynaecology rapid access clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Ethnicity data not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUsefulness of transvaginal ultrasound | Diagnostic test | – |
Primary outcome
To assess whether there is a higher incidence of uninformative ultrasound in black vs white women
Time frame: Review of patients who attended clinic in 2022
The need for further investigation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Endometrial Cancer Vaginal Fluid Specimen Collection Study
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Hysteroscopic Findings With Histopathologic Report of Endometrium in Patients With Postmenopausal Bleeding
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RecruitingObservational study
Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Bleeding and Endometrial Cancer, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether there is a higher incidence of uninformative ultrasound in black vs white women (time frame: Review of patients who attended clinic in 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.