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

January 20, 2025 updated by: ZIWIG

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
        • Not yet recruiting
        • CHU d'Angers
        • Contact:
      • Bordeaux, France
      • Bordeaux, France
        • Recruiting
        • Clinique Tivoli Ducos - IFEMENDO
        • Contact:
      • Caen, France, 14033
        • Recruiting
        • CHU Caen
        • Contact:
      • Dijon, France
        • Not yet recruiting
        • CGFL
        • Contact:
          • Hélène COSTAZ, Dr
          • Phone Number: +33 6 66 35 55 33
          • Email: hcostaz@cgfl.fr
      • Lyon, France
      • Neuilly-sur-Seine, France
        • Not yet recruiting
        • American Hospital of Paris
        • Contact:
      • Rennes, France
        • Not yet recruiting
        • CHU de Rennes Site Hôpital Sud
        • Contact:
      • Rennes, France
        • Not yet recruiting
        • Clinique La sagesse
        • Contact:
      • Rouen, France
      • Toulouse, France
      • Tours, France
        • Recruiting
        • CHU Bretonneau-Tours
        • Contact:
      • Villejuif, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic group

Clinically symptomatic females with one or more of the following gynecological pathology:

  • Endometriosis,
  • Adenomyosis,
  • Ovarian cysts,
  • Fibroids,
  • Ovarian cancer,
  • Cervical cancer
  • Uterine cancer.
Diagnostic test: Saliva sample
Saliva sample
Asymptomatic group

Asymptomatic females with:

  • Cervical dysplasia or cancer
  • A normal pap-smear (control)
Diagnostic test: Saliva sample
Saliva sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
Time Frame: 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.
Through the end of study inclusions, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZIWIG

Collaborators

Monitoring Force Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZWG-24-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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