Saliva Sample Study for Women With Gynecologic Conditions Before Surgery
Tests saliva RNA as a possible sign of gynecologic conditions in adult women.
Plain-language title generated from the registry record
Registry title: Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Key facts
- Where
- Angers, Bordeaux, Caen, Dijon, Lyon, Neuilly-sur-Seine, Rennes, Rouen, Toulouse, Tours, and Villejuif, FranceSee the 13 sites
Where in France
- CHU d AngersAngers, FranceNot yet recruiting
- Clinique Tivoli Ducos - IFEMENDOBordeaux, FranceTaking people
- Institut BergonieBordeaux, FranceNot yet recruiting
- CHU CaenCaen, FranceTaking people
- CGFLDijon, FranceNot yet recruiting
- CHU Lyon SudLyon, FranceNot yet recruiting
- American Hospital of ParisNeuilly-sur-Seine, FranceNot yet recruiting
- CHU de Rennes Site Hôpital SudRennes, FranceNot yet recruiting
- Clinique La sagesseRennes, FranceNot yet recruiting
- CHU RouenRouen, FranceTaking people
- Clinique PasteurToulouse, FranceTaking people
- CHU Bretonneau-ToursTours, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ZIWIG
- Trial code
- NCT06392997
- Record updated
- 23 January 2025
- Original description
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
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
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.
Inclusion: 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.
Exclusion: 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.