子宮內膜癌分子篩檢試劑套組開發案(III)

Endometrial cancer is a common gynecologic cancer with increasing incidence worldwide. It presents unspecific symptoms in patients, such as abnormal uterine bleeding; however, bleeding may be associated with other disorders; in fact, only 10% of postmenopausal cases are caused by endometrial cancer. The proportion is even less in premenopausal women. There are no screening methods for endometrial cancer so far. On the other hand, current procedures for detecting endometrial cancer are unreliable and invasive, such as endometrial biopsy, dilatation and curettage, hysteroscopy and transvaginal ultrasound. Although endometrial sampling by suction curettage tends to have higher sensitivity and specificity compared with transvaginal ultrasound, this invasive procedure can still have up to 54% of failure rate. Fractional dilatation and curettage is recommended by clinical guidelines, but it requires general anesthesia. DNA methylation in cancer has been studied widely for its role in changing the healthy regulation of gene expression to a disease pattern, and increasingly, it is used as biomarker for cancer detection or patient stratification. Our team has successfully identified several DNA methylated genes significantly related to endometrial cancer. This technology offers a novel panel of genes including BHLHE22 which can be used as biomarker for the diagnosis of endometrial cancer from cervical scrapings with high sensitivity and specificity. The present project will optimize testing conditions as an in vitro diagnostic kit and verify the performance using clinical specimen from multi-centers. This will be the first-in-class product in endometrial cancer screening.