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Recruiting Observational

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

NCT06392997 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Observational
Started
2024-12-05
Last updated
2025-01-23

Condition(s) studied

Gynecologic DiseaseGynecologic CancerEndometriosisOvarian CancerCyst OvaryFibroidCervical CancerUterine Cancer

Investigational drug(s) / intervention(s)

Saliva sample

Saliva sample: Saliva sample

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Subject of legal age (according to local legislation) and at least 18 years old 2. Subject (and if applicable her legal representative) having dated and signed the informed consent form 3. Subject with a medical insurance policy 4. Subject presenting to the department: 1. With Symptoms (bleeding and/or pain and/or clinically observed symptom) of one or more of the following pathologies (suspected undergoing diagnostic surgery/biopsy or diagnosed and before any curative treatment of the pathology): * Endometriosis * Adenomyosis, * Ovarian cysts, * Fibroids, * Ovarian cancer, * Cervical cancer, * Uterine cancer. 2. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment. 3. Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context. Exclusion Criteria: 1. Recent (\<1 month) or ongoing bacterial or viral infection 2. Known active oral or digestive mycosis 3. Evolving oral pathology, symptomatic or obvious 4. Known pregnancy 5. Known current non-gynecological pelvic pathology 6. Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma 7. Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma 8. Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion 9. Subject with significant difficulties reading or writing her language 10. Subject unable to comply with study and/or follow-up procedures 11. Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.

Primary outcome measure(s)

  • Area under the curve (AUC) of the Receiver Operating Curve (ROC) — Through the end of study inclusions, an average of 1 year
    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.

Trial sites (13)

FacilityCityRegionStatus
CHU d'Angers Angers France Not Yet Recruiting
Clinique Tivoli Ducos - IFEMENDO Bordeaux France Recruiting
Institut Bergonié Bordeaux France Not Yet Recruiting
CHU Caen Caen France Recruiting
CGFL Dijon France Not Yet Recruiting
CHU Lyon Sud Lyon France Not Yet Recruiting
American Hospital of Paris Neuilly-sur-Seine France Not Yet Recruiting
CHU de Rennes Site Hôpital Sud Rennes France Not Yet Recruiting
Clinique La sagesse Rennes France Not Yet Recruiting
CHU Rouen Rouen France Recruiting
Clinique Pasteur Toulouse France Recruiting
CHU Bretonneau-Tours Tours France Recruiting
Institut Gustave Roussy Villejuif France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06392997 on ClinicalTrials.gov ↗ ← All trials in France