Researchers developed a new, minimally invasive tool to detect endometrial cancer (EC) in women with postmenopausal bleeding using urine and vaginal samples, according to findings recently published in The Lancet Obstetrics, Gynaecology, & Women’s Health.
Postmenopausal bleeding is a potential warning sign of EC that means testing is needed to find the cause. However, testing is often painful and invasive, and repeat testing is sometimes necessary. The multicenter DEveloping Tests for Endometrial Cancer deTection (DETECT) study aimed to determine whether analyzing the urine and vaginal fluid for cancer cells, a process known as cytology, could accurately diagnose endometrial cancer.
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The study included 1,864 participants experiencing postmenopausal bleeding. Of these, 99 (5.3%) had a confirmed diagnosis of EC, and 16 had another pelvic cancer, including cervical, ovarian, colorectal or bladder cancer, leiomyosarcoma or metastatic pancreatic cancer.
Of the 99 patients with endometrial cancer, combined urine and vaginal cytology detected cancer cells in 80 cases, resulting in a sensitivity of 80.8%. The majority of the 19 cases initially missed by cytology were low-grade or early-stage.
Read more about endometrial cancer causes and risk factors
When the researchers conducted repeat sampling on 10 of the false negatives, four patients then tested positive. This suggests that repeat testing could improve the sensitivity of this test.
Standard clinical diagnosis was more difficult among the false negatives. Some required repeat biopsies, had a low tumor volume or only received a diagnosis upon specialist review. In addition, three of these individuals were diagnosed with cancer at least three months after their negative cytology test, raising the possibility that the cancer developed sometime in between.
Of those without EC, 92.6% of participants correctly tested negative, and 7.4% falsely tested positive. The investigators followed 130 false positives for one year. Upon follow-up, one of these patients was found to have grade 3, stage IB endometrial cancer and was reclassified as a true positive.
Among all participants testing positive, 38.1% truly had EC. This is primarily due to the low overall prevalence of EC in the sample, which causes the false positives to outnumber the true positives. Among all participants testing negative, though, 98.8% truly did not have EC.
Of those with a confirmed diagnosis, 88% tested positive on both urine and vaginal cytology. On the other hand, 43.1% of the false positives tested positive on both tests.
“Although the lower sensitivity of urogenital cytology for the detection of low-grade early-stage disease might necessitate repeat sampling or full diagnostic work-up in the event of ongoing symptoms, this novel test could still reduce the number of low-risk women receiving unnecessary, expensive, and potentially harmful invasive investigations,” the authors concluded.
