Tamoxifen,Abnormal Bleeding and the role of Saline Infusion Sonography
Research type
Research Study
Full title
Tamoxifen and Abnormal Uterine Bleeding: the role of Saline Infusion Sonography and correlation with Hysteroscopy and Histopathology
IRAS ID
245043
Contact name
Archana Vasireddy
Contact email
Sponsor organisation
R&I Manager, King's College Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, days
Research summary
The study aims to assess the sensitivity of the saline infusion sonography (SIS) in identifying problems with the lining of the womb in women using tamoxifen and experiencing abnormal bleeding from the womb.
Tamoxifen is used as adjuvant treatment in breast cancer – the commonest cancer affecting women in the U.K. Women using tamoxifen are at risk of abnormal bleeding from the womb. This is because of the effect of tamoxifen on the lining of the womb (endometrium). Any women reporting abnormal bleeding must be assessed by a gynaecologist as there is an increased risk of overgrowth or polyp formation in the lining of the womb and even womb cancer. Up to 50% of all women using tamoxifen can suffer with abnormal bleeding.
Previously, research has found that SIS can be used to more accurately assess problems within the womb lining than ultrasound alone. It also helps differentiate true overgrowth of the womb lining rather than the other harmless effects of tamoxifen which can mimic this appearance on ultrasound alone.
Current practice in the U.K. is to perform an ultrasound for women who have bleeding whilst on tamoxifen and a subsequent hysteroscopy if any changes are seen within the womb lining. The hysteroscopy (camera test) looking inside the womb can be performed whilst awake or under a general anaesthetic.
The saline infusion sonography has yet to be widely adopted in routine practice and this study aims to looks at how this procedure performs in comparison to ultrasound and hysteroscopy and findings at biopsy (histopathology). The acceptability of SIS as a procedure to women evaluating pain and anxiety scores will also be assessed.REC name
London - Central Research Ethics Committee
REC reference
18/LO/1554
Date of REC Opinion
4 Oct 2018
REC opinion
Favourable Opinion