NCT06392997 Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
| NCT ID | NCT06392997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ZIWIG |
| Condition | Gynecologic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2024-12-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06392997 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecologic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06392997 currently recruiting?
Yes, NCT06392997 is actively recruiting participants. Contact the research team at sofiane.bendifallah@yahoo.fr for enrollment information.
Where is the NCT06392997 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Bordeaux, France, Caen, France and 9 additional locations.
Who is sponsoring the NCT06392997 clinical trial?
NCT06392997 is sponsored by ZIWIG. The trial plans to enroll 2,500 participants.