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

NCT06392997 — Recruiting, 2500 participants, ZIWIG

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RegistryNCT06392997, acronym GynRNA
StatusRecruiting
Study typeObservational
Enrollment2500 (Estimated)
SponsorZIWIG (Industry); collaborators: Monitoring Force Group
ConditionsGynecologic Disease, Gynecologic Cancer, Endometriosis, Ovarian Cancer, Cyst Ovary, Fibroid, Cervical Cancer, Uterine Cancer
InterventionsSaliva sample (Diagnostic test)
Datesstart 2024-12-05, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-05-01, last updated 2025-01-23
Locations13 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Gynecologic Disease All trials for Gynecologic Cancer All trials of Saliva sample

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Symptomatic groupDiagnostic Test: Saliva sampleClinically symptomatic females with one or more of the following gynecological pathology: * Endometriosis, * Adenomyosis, * Ovarian cysts, * Fibroids, * Ovarian cancer, * Cervical cancer * Uterine cancer.
Asymptomatic groupDiagnostic Test: Saliva sampleAsymptomatic females with: * Cervical dysplasia or cancer * A normal pap-smear (control)
  • Saliva sample (Diagnostic test): Saliva sample

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (13)

FacilityCityCountryStatus
CHU d'AngersAngersFranceNot yet recruiting
Clinique Tivoli Ducos - IFEMENDOBordeauxFranceRecruiting
Institut BergoniéBordeauxFranceNot yet recruiting
CHU CaenCaenFranceRecruiting
CGFLDijonFranceNot yet recruiting
CHU Lyon SudLyonFranceNot yet recruiting
American Hospital of ParisNeuilly-sur-SeineFranceNot yet recruiting
CHU de Rennes Site Hôpital SudRennesFranceNot yet recruiting
Clinique La sagesseRennesFranceNot yet recruiting
CHU RouenRouenFranceRecruiting
Clinique PasteurToulouseFranceRecruiting
CHU Bretonneau-ToursToursFranceRecruiting
Institut Gustave RoussyVillejuifFranceNot yet recruiting