1. In a proof-of-concept study of 35 patients with ovarian or endometrial cancer, the use of uterine cavity lavage successfully produced malignant cells for DNA mutation analysis in all cases.
Evidence Rating Level: 3 (Average)
Study Rundown: Ovarian cancer (OC) and endometrial cancer (EC) account for a significant proportion of deaths related to gynecologic cancers. A significant proportion of these patients present with advanced disease, as there are limited tools for screening and early diagnosis. Previous studies have demonstrated that liquid Papanicolaou tests may collect shed cancer cells within the cervix. Thus, the purpose of this proof-of-concept study was to investigate whether lavage of the uterine cavity can be used to collect and identify gynecological cancer cells.
The trial performed uterine cavity lavage in 35 patients with known diagnosis of OC and EC along with 27 patients with benign gynecological conditions. Specific mutations within these malignant cells were detected using next-generation sequencing and singleplex amplification analysis. At the conclusion of the trial, uterine cavity lavage produced adequate malignant cells for analysis in all patients. Furthermore, more than 80% of the OC and EC patient cohort had specific mutations detected in sequencing analysis. Of note, the specific mutations in the OC and EC cohort were significantly different from that of the benign disease cohort. The results of this trial support further investigations of uterine cavity lavage as a potential diagnostic test for OC and EC. The study was limited by the small sample size and the lack of patients with early disease. Additional large, prospective trials in patients are needed to determine the utility of uterine cavity lavage as a diagnostic and potential screening tool for OC and EC.
In-Depth [prospective cohort]: This study included a total of 65 patients with OC (n = 30), EC (n = 5), benign gynecologic lesions (n = 27), and other malignancies (n = 3). Patients were excluded if they had a history of greater than one primary malignancy, previous tubal ligation or germline mutations. All uterine lavage specimens were analyzed using next-generation sequencing (NGS) or singleplex amplification and compared with the corresponding tumor tissue analysis. At the conclusion of the trial, all lavage samples returned sufficient amounts of DNA for testing. Overall, 80% of the OC cohort and 100% of the EC cohort had specific mutations detected on NGS or singleplex amplification. The majority of patients with OC had TP53 mutations. In the benign gynecological disease cohort, the majority of patients demonstrated specific mutation in the KRAS gene, which was not significantly detected in the OC or EC mutational analysis.
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