About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject of legal age (according to local legislation) and at least 18 years old
Subject (and if applicable her legal representative) having dated and signed the informed consent form
Subject with a medical insurance policy
Endometriosis
Disqualifiers
Recent (<1 month) or ongoing bacterial or viral infection
Known active oral or digestive mycosis
Evolving oral pathology, symptomatic or obvious
Known pregnancy
Trial population
The study populations is constituted of s: 1. Clinically symptomatic females with one or more of the following gynecological pathology: * Endometriosis, * Adenomyosis, * Ovarian cysts, * Fibroids, * Ovarian cancer, * Cervical cancer * Uterine cancer. 2. Asymptomatic females with: * cervical dysplasia or cancer * a normal pap-smear (control)
Trial design
Cohort
Prospective
Treatments tested in this trial
Saliva sample
Diagnostic testSaliva sample
Treatment groups
Trial outcomes
Primary outcomes
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
Identify a diagnostic signature for each pathology (Endometriosis / Adenomyosis / Ovarian cysts / Fibroids / Cervical Displasia / Ovarian cancer / Cervical cancer /Uterine cancer) by analyzing of coding and non-coding RNA contained in the saliva.
Sponsors and contacts
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ZIWIG
Lead sponsor
Monitoring Force Group
Collaborator