Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
CHU d'Angers
NOT_YET_RECRUITING
Angers
Clinique Tivoli Ducos - IFEMENDO
RECRUITING
Bordeaux
Institut Bergonié
NOT_YET_RECRUITING
Bordeaux
CHU Caen
RECRUITING
Caen
CGFL
NOT_YET_RECRUITING
Dijon
CHU Lyon Sud
NOT_YET_RECRUITING
Lyon
American Hospital of Paris
NOT_YET_RECRUITING
Neuilly-sur-seine
CHU de Rennes Site Hôpital Sud
NOT_YET_RECRUITING
Rennes
Clinique La sagesse
NOT_YET_RECRUITING
Rennes
CHU Rouen
RECRUITING
Rouen
Clinique Pasteur
RECRUITING
Toulouse
CHU Bretonneau-Tours
RECRUITING
Tours
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Contact Information
Primary
Sofiane Bendifallah, MD
sofiane.bendifallah@yahoo.fr
+33146412699
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 2500
Treatments
Symptomatic group
Clinically symptomatic females with one or more of the following gynecological pathology:~* Endometriosis,~* Adenomyosis,~* Ovarian cysts,~* Fibroids,~* Ovarian cancer,~* Cervical cancer~* Uterine cancer.
Asymptomatic group
Asymptomatic females with:~* Cervical dysplasia or cancer~* A normal pap-smear (control)
Sponsors
Collaborators: Monitoring Force Group
Leads: ZIWIG

This content was sourced from clinicaltrials.gov