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ACTIVE NOT RECRUITING
NCT05514028

Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin

Sponsor: ZIWIG

View on ClinicalTrials.gov

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

OTHER

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