Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saliva sample.
- Who it may be relevant to
- Registry conditions: Gynecologic Disease, Gynecologic Cancer, Endometriosis, Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test Saliva sample
Saliva sample
Primary outcome measures
- Area under the curve (AUC) of the Receiver Operating Curve (ROC) [Time frame: Through the end of study inclusions, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Recent (<1 month) or ongoing bacterial or viral infection
- Known active oral or digestive mycosis
- Evolving oral pathology, symptomatic or obvious
- Known pregnancy
- Known current non-gynecological pelvic pathology
- 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
- Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
- Subject with significant difficulties reading or writing her language
- Subject unable to comply with study and/or follow-up procedures
- Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 13 centers
- CHU d'Angers — Angers
- Clinique Tivoli Ducos - IFEMENDO — Bordeaux
- Institut Bergonié — Bordeaux
- CHU Caen — Caen
- CGFL — Dijon
- CHU Lyon Sud — Lyon
- American Hospital of Paris — Neuilly-sur-Seine
- CHU de Rennes Site Hôpital Sud — Rennes
- … and 5 more centers
Identifiers
NCT: NCT06392997 · ZWG-24-01