NCT05514028

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 746 (actual)
• Sponsor: ZIWIG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ovarian Cancer
• Ovarian Cyst Benign
• Borderline Ovarian Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-05-04
• Primary completion: 2025-04-10
• Completion: 2027-04-01
• First posted: 2022-08-24
• Last updated: 2026-03-30

Locations

21 sites across 3 countries: France, Switzerland, Tunisia