Analyzing saliva for diagnosing gynecological conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify a diagnostic signature for various gynecological pathologies by analyzing coding and non-coding RNA in saliva samples from patients scheduled for surgery. It includes both symptomatic patients with conditions such as endometriosis and ovarian cancer, as well as asymptomatic individuals undergoing routine screenings. The study is non-interventional, meaning that patient care pathways and treatment plans will remain unchanged throughout the study. The research is conducted across multiple gynecology and oncology departments internationally.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinique Tivoli Ducos - IFEMENDO
  Bordeaux, France Recruiting
• CHU Caen
  Caen, France Recruiting
• CHU Rouen
  Rouen, France Recruiting
• Clinique Pasteur
  Toulouse, France Recruiting
• CHU Bretonneau-Tours
  Tours, France Recruiting
• CHU d'Angers
  Angers, France Not yet recruiting

Study contacts

• Study coordinator: Sofiane Bendifallah, MD
• Email: sofiane.bendifallah@yahoo.fr
• Phone: +33146412699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.