Under construction – not a live service
Sign in
Taking people in FranceNo phase

Saliva Sample Study for Women With Gynecologic Conditions Before Surgery

Tests saliva RNA as a possible sign of gynecologic conditions in adult women.

Key facts

Who runs it
ZIWIG
Where
Angers, Bordeaux, Caen, Dijon, Lyon, Neuilly-sur-Seine, Rennes, Rouen, Toulouse, Tours, and Villejuif, FranceSee the 13 sites
Trial code
Registry title
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Status
Recruiting
People taking part
2,500 people, planned
Started
5 Dec 2024
Expected to end
Dec 2026
Type of study
Observational, 2 groups
Treatments tested
  • Saliva sample
Record updated
23 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women who have symptoms of a gynecologic condition, or who have no symptoms and are having a pap smear. A saliva sample is collected.

Age
18 years or older
Sex
Women only
Disease stage
Symptoms of endometriosis, adenomyosis, ovarian cysts, fibroids, or ovarian, cervical or uterine cancer, before any treatment meant to remove the disease. Women with no symptoms can join if their pap smear shows cervical dysplasia or cervical cancer, or if they are having a screening pap smear.
Earlier treatment
No chemotherapy, radiotherapy, or full or partial surgical removal of the gynecologic condition before joining.

Main reasons for not taking part

  • Bacterial or viral infection in the last month or ongoing
  • Known pregnancy
  • Breast cancer or any non-gynecological cancer, except basal cell carcinoma
  • Cancer treated within the last 5 years, except basal cell carcinoma
  • Active or obvious oral disease, or known oral or digestive fungal infection

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Subject of legal age (according to local legislation) and at least 18 years old
  • Subject (and if applicable her legal representative) having dated and signed the informed consent form
  • Subject with a medical insurance policy
  • Subject presenting to the department:; 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; Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment; Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context

Who cannot take part

  • Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
  • Participation in an interventional study with investigational drug or in the exclusion period of an interventional study
  • Recent (<1 month) or ongoing bacterial or viral infection
  • Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma
  • Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma
  • Known active oral or digestive mycosis
  • Evolving oral pathology, symptomatic or obvious
  • Known pregnancy
  • Known current non-gynecological pelvic pathology
  • Subject with significant difficulties reading or writing her language
  • Subject unable to comply with study and/or follow-up procedures

Where in France

  • CHU d AngersAngers, FranceContact: Léa DELBOS, DrNot yet recruiting
  • Clinique Tivoli Ducos - IFEMENDOBordeaux, FranceContact: Horace ROMAN, PrTaking people
  • Institut BergonieBordeaux, FranceContact: Frédéric GUYON, DrNot yet recruiting
  • CHU CaenCaen, FranceContact: Raffaèle Fauvet, PrTaking people
  • CGFLDijon, FranceContact: Hélène COSTAZ, DrNot yet recruiting
  • CHU Lyon SudLyon, FranceContact: François GOLFIER, PrNot yet recruiting
  • American Hospital of ParisNeuilly-sur-Seine, FranceContact: Sofiane Bendifallah, MDNot yet recruiting
  • CHU de Rennes Site Hôpital SudRennes, FranceContact: Vincent LAVOUE, PrNot yet recruiting
  • Clinique La sagesseRennes, FranceContact: Claire Marie ROGER, DrNot yet recruiting
  • CHU RouenRouen, FranceContact: Morgane PERRIN, DrTaking people
  • Clinique PasteurToulouse, FranceContact: Ludivine Genre, DrTaking people
  • CHU Bretonneau-ToursTours, FranceContact: Lobna OULDAMER, PrTaking people
  • Institut Gustave RoussyVillejuif, FranceContact: Alexandra LEARY, DrNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • 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.

    Treatment: Saliva sample

  • Asymptomatic group

    Asymptomatic females with: * Cervical dysplasia or cancer * A normal pap-smear (control)

    Treatment: Saliva sample

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Plain-language title
Saliva Sample Study for Women With Gynecologic Conditions Before SurgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 January 2025