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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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):
. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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