Status:
RECRUITING
Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.
Lead Sponsor:
Imperial College Healthcare NHS Trust
Conditions:
Endometrial Cancer
Post-Menopausal Bleeding
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
TITLE Pipelle® under Ultrasound Guidance (PUG) to investigate post-menopausal bleeding: Randomised Controlled Trial BACKGROUND Women who are suspected of having endometrial cancer (cancer of the inne...
Detailed Description
BACKGROUND Uterine cancer is the most common gynaecological cancer in the United Kingdom with approximately 9,400 new cases diagnosed each year, over 95% arising from the endometrium. Almost all endom...
Eligibility Criteria
Inclusion
- All patients with post-menopausal bleeding who require an endometrial biopsy.
- Further details:
- Post-menopausal bleeding is defined as bleeding one year after a woman's last menstrual period or bleeding six months after starting continuous combined hormone replacement therapy.
- There is no upper age limit, however all patients must be 18 or above.
- Strict ultrasound criteria will be followed:
- Endometrium ≥5mm: this is the current cut off used by Imperial College Healthcare NHS Trust for a biopsy to be indicated in the context of post-menopausal bleeding.
- Smooth, homogenous endometrium with a clearly defined border.
Exclusion
- Focal endometrial pathology (including but not limited to endometrial polyps, type 0-2 fibroids, uterine septa and other uterine structural abnormalities).
- Suspicion of non-benign myometrial pathology.
- History of endometrial cancer or endometrial hyperplasia.
- History of cervical cancer.
- Virgo intacta.
- Inability to tolerate vaginal examination.
- Inability to consent.
- The denial or withdrawal of informed written consent.
Key Trial Info
Start Date :
July 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 23 2027
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06501846
Start Date
July 23 2024
End Date
July 23 2027
Last Update
July 15 2024
Active Locations (1)
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1
Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare Trust
London, United Kingdom, W12 0HS