Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology (NCT06392997) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
France2,500 participantsStarted 2024-12-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
ā. Subject of legal age (according to local legislation) and at least 18 years old
ā. Subject (and if applicable her legal representative) having dated and signed the informed consent form
ā. Subject with a medical insurance policy
ā. Subject presenting to the department:
ā. 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):
ā. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.
ā. Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context.
Exclusion criteria
ā. Recent (\<1 month) or ongoing bacterial or viral infection
ā. Known active oral or digestive mycosis
What they're measuring
1
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
Timeframe: Through the end of study inclusions, an average of 1 year
ā. Evolving oral pathology, symptomatic or obvious
ā. Known pregnancy
ā. Known current non-gynecological pelvic pathology
ā. Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma
ā. Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma
ā. Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion