Pilot study of the lavage of the uterine cavity for the diagnosis of serous tubal intraepithelial carcinoma

High grade serous ovarian cancer (HGSC) is the leading cause of death from
gynecologic malignancy in western civilized countries. It is usually detected
at an advanced stage and five-year survival rates are in the range of 10 to 30
%. Definitive diagnosis of HGSC mostly relies on surgical confirmation and
there is a need for an effective test for early detection. The specificity of
current diagnostic tools is low and ineffective at detecting HGSC early enough
to improve clinical outcomes. Recent findings have shown that it is possible to
detect ovarian cancer cells in lavage fluid from the uterus and proximal tubes
very effectively.
There is increasing evidence that a large proportion of not only familial HGSC
develop primarily in the lining of the fallopian tube. If cells from these
serous tubal intraepithelial carcinomas can be detected in lavage fluid from
the uterus and proximal fallopian tubes, it would be possible to detect ovarian
cancer in a pre-malignant stage, making it much easier to treat and increase
the survival significantly.

Detect exfoliated cells from STICs in lavage fluid from the uterine cavity and
proximal fallopian tubes

Prospective multicentre cohort study

The risk that STIC cells will get washed in to the peritoneal cavity during the
lavage and form metastases in the peritoneal cavity is remote. This risk is
balanced against the benefit of developing a screening test or early detection
test for STICs. Currently, women with germ line mutations in the BRCA 1/2 genes
are counselled that risk reducing bilateral salpingo-oophorectomy should be
performed as soon as childbearing is complete or by the age of 35 to 40 years,
since the benefit diminishes with age. An effective screening test for STICs
will hopefully allow high risk women to safely and with less anxiety defer risk
reducing bilateral salpingo-oophorectomy until childbearing is completed or
even until menopause, thereby preventing premature menopause. With adequate
test performance women might even be spared from risk reducing bilateral
salpingo-oophorectomy completely.
Individual patients will not benefit from participating in this study, nor will
there be any burden, as the lavage will be performed prior to the surgery, when
the patient is already under anaesthesia.