Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?

NCT03207126 | Completed Results

• 1 other identifier: 16HH3687 USS guided biopsy EC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Assess accuracy of histological diagnosis using ultrasound guided biopsy for women with suspected endometrial cancer (as an alternative to hysteroscopy guided biopsy). All women presenting to clinic with suspected endometrial cancer will have an internal ultrasound. If the endometrial lining is thickened an endometrial biopsy will be performed. This can sometimes be done in an outpatient clinic, or sometimes a hysteroscopy and biopsy is needed (on a different day). Hysteroscopy guided biopsy has the advantage of enabling the clinician to perform directed biopsies under vision. Ultrasound guided biopsy is a ubiquitous procedure when used elsewhere in the body however it is not routinely used in this context. It does have the advantage of being easily performed on the same day as the first consultation. In this pilot study the diagnostic ability and tolerability of ultrasound guided biopsy of women with suspected cancer will be assessed as an alternative to hysteroscopy guided biopsy.

Conditions

Endometrial Cancer; Endometrial Neoplasms; Endometrial Hyperplasia; Endometrial Polyp

Keywords

Ultrasound; Biopsy; Endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Whose Sample Was Successfully Analysed by Histological Diagnosis

  All samples taken using ultrasound guided biopsy were analysed by histology lab. If they had sufficient tissue to give a diagnosis (benign, pre-malignant or malignant) this was deemed successful. It is deemed successful if there was sufficient tissue to give a histological analysis. So overall there will be a percentage success rate (number of tissue samples sufficient/number of tissue samples taken). Each patient would have had one sample.

  1.5 years

Secondary Outcomes (1)

• Patient Satisfaction of Ultrasound Guided Biopsy by Questionnaire

  1.5 years

Study Arms (1)

Women needing endometrial biopsy

OTHER

All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first.

Diagnostic Test: Ultrasound guided biopsy

Interventions

Ultrasound guided biopsy DIAGNOSTIC_TEST

For women needed a hysteroscopy guided biopsy as part of routine standard of care, women will now receive an ultrasound guided biopsy first

Women needing endometrial biopsy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study is looking at endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.

You may not qualify if:

• Anyone lacking capacity. \<18years old. Pregnant.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Queen Charlotte and Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Diana Marcus
• Organization: Imperial College London

diana.marcus@nhs.net

07525133957

Study Officials

• Diana Marcus, MB BS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women offered and received ultrasound guided biopsy

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: June 13, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)