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Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin
Sponsor: ZIWIG
Summary
OVAmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in 8 obstetrics and gynecology departments in France; in order to describe the evolution of salivary miRNA expression between the pre-operative and post-therapy visits according to the type of mass. In time, the clinical application will be to significantly reduce the time to diagnosis and improve the care pathway for ovarian adnexal mass. The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI) and requiring surgical management in routine care. 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 (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF. In this study, the management and follow-up of patients : * Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits, * Are not modified in comparison with the usual follow-up, except for the performance of the Collection of saliva
Official title: Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin - OVAmiARN Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
746
Start Date
2022-05-04
Completion Date
2027-04
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
Salivary samples
For patients with a benign ovarian cyst, 1 saliva sample taken at 3 times (concomitant with a visit performed in routine care): * During the inclusion visit, * At the postoperative visit, * At the 6-month follow-up visit For patients with ovarian cancer, 1 saliva sample taken at different times (concomitant with a visit performed in routine care): * At the inclusion visit, * During the postoperative visit, * At the follow-up visits (6 months post-surgery and then every 6 months until 24 months) For patients with a borderline ovarian tumor, 1 saliva sample taken at different times (concomitant with a visit performed in routine care): * At the inclusion visit, * During the postoperative visit, * During pre- and post-chemotherapy visits (before and after each cycle) * During follow-up visits (every 4 months until 24 months)
Locations (21)
CHU de Caen
Caen, Calvados, France
CGFL
Dijon, Côte d'Or, France
Institut Bergonié
Bordeaux, Gironde, France
CHU Strasbourg
Strasbourg, Haut-Rhin, France
CHU Toulouse
Toulouse, Haute-Garonne, France
CHP St Grégoire
Saint-Grégoire, Ille Et Villaine, France
Hôpital BICETRE
Le Kremlin-Bicêtre, Val de Marne, France
Institut Gustave Roussy
Villejuif, Val de Marne, France
CHU Angers
Angers, France
CH Bastia
Bastia, France
CHU Lyon Sud / Hospices Civils de Lyon
Lyon, France
Centre Antoine Lacassagne
Nice, France
CH Niort
Niort, France
CHU Tenon
Paris, France
CHU Rennes
Rennes, France
Clinique La sagesse
Rennes, France
CHU Rouen, Hôpital de Bois-Guillaume
Rouen, France
Clinique Pasteur
Toulouse, France
CHRU Bretonneau-Tours
Tours, France
Universitätsklinik für Frauenheilkunde
Bern, Switzerland
Centre de Maternité et de Néonatologie Wassila Bourguiba
Tunis, Tunisia