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

Sponsor
ZIWIG
Study ID
NCT06392997
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Saliva sample — DIAGNOSTIC_TEST
    Saliva sample

Study Details

GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva. The study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian/cervical/uterine cancer) and asymptomatic females. The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the local recommendations.

Key Dates

First listed
May 1, 2024
Start date
Dec 5, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: Symptomatic group
    Clinically symptomatic females with one or more of the following gynecological pathology: * Endometriosis, * Adenomyosis, * Ovarian cysts, * Fibroids, * Ovarian cancer, * Cervical cancer * Uterine cancer.
  • Arm: Asymptomatic group
    Asymptomatic females with: * Cervical dysplasia or cancer * A normal pap-smear (control)

Primary Outcome Measure

Area under the curve (AUC) of the Receiver Operating Curve (ROC) [ Time Frame: Through the end of study inclusions, an average of 1 year ]

Central Contacts

Find similar trials

Nationwide
Cervical cancer trialsEndometriosis trialsOvarian cancer trialsEndometrial cancer trialsOncology trialsGynecologic oncology trialsWomen's health trialsFertility trials

Related Studies