Evaluation of Salivary RNA for Diagnosing Gynecologic Pathologies in Women Scheduled for Surgery

What this Trial Is About

Researchers are studying gynecological conditions including endometriosis, adenomyosis, ovarian cysts, fibroids, and various gynecologic cancers such as ovarian, cervical, and uterine cancer. This international, multicenter, observational study aims to find a diagnostic signature for these gynecological diseases by analyzing the coding and non-coding RNA present in saliva samples from symptomatic and asymptomatic female patients. The study does not change the usual care, treatment, or diagnostic procedures for participants. The study collects saliva samples from women scheduled for surgery or biopsy for suspected or diagnosed gynecologic pathologies, as well as from asymptomatic women undergoing cervical cancer screening. Participants are managed according to local medical recommendations without modification. The intervention consists solely of collecting saliva samples for RNA analysis, with no treatment or medication administered as part of the study. Participants will provide informed consent and be followed for about one year. Researchers will evaluate the diagnostic accuracy of salivary RNA by measuring the area under the curve (AUC) of the receiver operating curve (ROC). Participants continue their usual medical care and undergo necessary examinations and follow-up as per their healthcare providers. The study includes monitoring of safety and adherence to study procedures but does not involve any changes to treatment or additional interventions beyond saliva collection.

Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology