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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorZIWIG

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Saliva sample

    Diagnostic test

    Saliva sample

Treatment groups

2,500 Participants
are divided into 2 treatment groups
Group A: Symptomatic group1 intervention
Group B: Asymptomatic group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through the end of study inclusions, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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ZIWIG

Lead sponsor

Monitoring Force Group

Collaborator