Study of Salivary RNA to Diagnose Gynecologic Diseases and Cancers in Women Scheduled for Surgery or Screening

What this Trial Is About

Researchers are conducting an international non-interventional study to identify diagnostic markers for gynecological diseases by analyzing coding and non-coding RNA in saliva samples. The study focuses on symptomatic females with gynecological conditions such as endometriosis, adenomyosis, ovarian cysts, fibroids, and gynecological cancers, as well as asymptomatic females. Participants will continue their usual medical care without changes to treatment or diagnostic procedures. Participants are grouped into symptomatic females who have one or more specified gynecological pathologies and asymptomatic females either with cervical dysplasia or cancer or with normal pap-smears as controls. The study involves collecting saliva samples to analyze RNA content as a diagnostic tool. Patients will undergo their planned surgeries or biopsies according to standard care. During the study, participants will provide saliva samples and have their clinical status recorded. Researchers will measure the diagnostic accuracy of RNA markers by evaluating the area under the curve AUC of a receiver operating characteristic ROC curve over about one year. No additional treatment changes or interventions will be made. The total participation duration depends on the timing of scheduled surgeries and follow-ups.

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