NCT06392997Recruiting
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2500 (estimated)
- First submitted
- 9 Apr 2024
- Start date
- 5 Dec 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- ZIWIG
- Diseases
- Endometriosis, Cervical cancer, Ovarian cancer
- NCT number
- NCT06392997
What you commit to
- Study type: Observational
- Planned participants: 2500
- From 5 Dec 2024 to the primary completion date, Dec 2026
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Not yet recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Clinique Tivoli Ducos - IFEMENDO Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CGFL Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| CHU Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| American Hospital of Paris Coordinator of this site? Confirm its status | Neuilly-sur-Seine | France | Not yet recruiting |
| Clinique La sagesse Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| CHU de Rennes Site Hôpital Sud Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHU Bretonneau-Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.