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

Recruiting

• Conditions: Uterine Cancer; Gynecologic Disease; Fibroid; Cyst Ovary; Endometriosis; Cervical Cancer; Gynecologic Cancer; Ovarian Cancer
• Interventions: Diagnostic Test: Saliva sample

• Registration Number: NCT06392997
• Lead Sponsor: ZIWIG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-05-01
• Study Start: 2024-12-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (13)

CGFL; 🇫🇷 Dijon, France

CHU Lyon Sud; 🇫🇷 Lyon, France

American Hospital of Paris; 🇫🇷 Neuilly-sur-Seine, France

CHU d'Angers; 🇫🇷 Angers, France

Clinique Tivoli Ducos - IFEMENDO; 🇫🇷 Bordeaux, France

Institut Bergonié; 🇫🇷 Bordeaux, France

CHU Caen; 🇫🇷 Caen, France

CHU de Rennes Site Hôpital Sud; 🇫🇷 Rennes, France

Clinique La sagesse; 🇫🇷 Rennes, France

CHU Rouen; 🇫🇷 Rouen, France

Clinique Pasteur; 🇫🇷 Toulouse, France

CHU Bretonneau-Tours; 🇫🇷 Tours, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France