Analyzing saliva for diagnosing gynecological conditions
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
This study is testing if analyzing saliva can help doctors diagnose gynecological conditions like endometriosis and ovarian cancer in both patients with symptoms and those without.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ziwig Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites (Angers and 12 other locations) |
| Trial ID | NCT06392997 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with symptoms of gynecological conditions or those undergoing routine cervical cancer screenings.
Not a fit: Patients with recent or ongoing infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive diagnostic tool for early detection of gynecological diseases.
How similar studies have performed: While the approach of using saliva for diagnostic purposes is gaining interest, this specific methodology for gynecological pathologies is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Angers and 12 other locations
- CHU d'Angers — Angers, France (Not_yet_recruiting)
- Clinique Tivoli Ducos - IFEMENDO — Bordeaux, France (Recruiting)
- Institut Bergonié — Bordeaux, France (Not_yet_recruiting)
- CHU Caen — Caen, France (Recruiting)
- Cgfl — Dijon, France (Not_yet_recruiting)
- CHU Lyon Sud — Lyon, France (Not_yet_recruiting)
- American Hospital of Paris — Neuilly-sur-Seine, France (Not_yet_recruiting)
- CHU de Rennes Site Hôpital Sud — Rennes, France (Not_yet_recruiting)
- Clinique La sagesse — Rennes, France (Not_yet_recruiting)
- CHU Rouen — Rouen, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- CHU Bretonneau-Tours — Tours, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Sofiane Bendifallah, MD
- Email: sofiane.bendifallah@yahoo.fr
- Phone: +33146412699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.