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

Last updated: January 20, 2025
Sponsor: ZIWIG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Endometriosis

Ovarian Cancer

Treatment

Saliva sample

Clinical Study ID

NCT06392997
ZWG-24-01
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 theinformed consent form

  3. Subject with a medical insurance policy

  4. Subject presenting to the department:

  5. With Symptoms (bleeding and/or pain and/or clinically observed symptom) of oneor more of the following pathologies (suspected undergoing diagnosticsurgery/biopsy or diagnosed and before any curative treatment of thepathology):

  • Endometriosis
  • Adenomyosis,
  • Ovarian cysts,
  • Fibroids,
  • Ovarian cancer,
  • Cervical cancer,
  • Uterine cancer.
  1. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancerand before any curative treatment.

  2. Asymptomatic undergoing a pap smear for cervical cancer screening in agynecological follow-up context.

Exclusion

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 theexception of basal cell carcinoma

  7. Subject with a history of treated cancer within the last 5 years with the exceptionof basal cell carcinoma

  8. Subject who has already received chemotherapy or radiotherapy or undergone completeor 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 theexclusion period of an interventional study.

Study Design

Total Participants: 2500
Treatment Group(s): 1
Primary Treatment: Saliva sample
Phase:
Study Start date:
December 05, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • CHU d'Angers

    Angers,
    France

    Site Not Available

  • Clinique Tivoli Ducos - IFEMENDO

    Bordeaux,
    France

    Active - Recruiting

  • Institut Bergonié

    Bordeaux,
    France

    Site Not Available

  • CHU Caen

    Caen, 14033
    France

    Active - Recruiting

  • CGFL

    Dijon,
    France

    Site Not Available

  • CHU Lyon Sud

    Lyon,
    France

    Site Not Available

  • American Hospital of Paris

    Neuilly-sur-Seine,
    France

    Site Not Available

  • CHU de Rennes Site Hôpital Sud

    Rennes,
    France

    Site Not Available

  • Clinique La sagesse

    Rennes,
    France

    Site Not Available

  • CHU Rouen

    Rouen,
    France

    Active - Recruiting

  • Clinique Pasteur

    Toulouse,
    France

    Active - Recruiting

  • CHU Bretonneau-Tours

    Tours,
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

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