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

Recruiting

• Conditions: Ovarian Cyst Benign; Borderline Ovarian Cancer; Ovarian Cancer
• Interventions: Other: Salivary samples

• Registration Number: NCT05514028
• Lead Sponsor: ZIWIG

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-04
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Patient over 18 years of age,
• A patient with an ovarian adnexal mass diagnosed by clinical examination and imaging and likely to be ovarian cancer, a borderline tumour or a benign cyst,
• Patient with an indication for surgery
• Patient has dated and signed the consent form,
• Patient affiliated to the healthcare system,

Exclusion Criteria

• Pregnant patient
• Patient infected with human immunodeficiency virus (HIV),
• Patient with significant difficulties in reading or writing the French language.
• Patient with another diagnosed cancer
• Patient with a history of cancer less than 5 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Borderline Ovarian Cancer	Salivary samples	30 patients
Cyst Benign	Salivary samples	100 patients
Ovarian Cancer	Salivary samples	120 patients

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of the Receiver Operating Curve (ROC)	Through the end of study inclusions, an average of 6 months	Identifying a signature of ovarian cancer diagnosis by analysis of coding and non-coding RNAs in the saliva of subjects

Trial Locations

Locations (12)

CHU Lyon Sud / Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU de Caen; 🇫🇷 Caen, Calvados, France

CH Bastia; 🇫🇷 Bastia, France

CHU Tenon; 🇫🇷 Paris, France

CHU Angers; 🇫🇷 Angers, France

CHRU Bretonneau-Tours; 🇫🇷 Tours, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

CH Niort; 🇫🇷 Niort, France

CHU Rennes; 🇫🇷 Rennes, France

Clinique La sagesse; 🇫🇷 Rennes, France

CHU Rouen, Hôpital de Bois-Guillaume; 🇫🇷 Rouen, France

Clinique Pasteur; 🇫🇷 Toulouse, France