RecruitingNCT05514028

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


Sponsor

ZIWIG

Enrollment

250 participants

Start Date

May 4, 2022

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether certain RNA molecules found in saliva can help determine whether a mass found near the ovary is cancerous, pre-cancerous (borderline), or benign (non-cancerous). The goal is to develop a simple, non-invasive saliva test to help diagnose ovarian cancer earlier. **You may be eligible if...** - You are 18 years or older - You have been found to have an ovarian or adnexal (near the ovary) mass on examination or imaging - Your mass is suspected to be ovarian cancer, a borderline tumor, or a benign cyst - You are scheduled for surgery to remove or evaluate the mass - You are covered by or affiliated with the French healthcare system **You may NOT be eligible if...** - You are pregnant - You are HIV-positive - You have another active cancer, or have had cancer in the past 5 years - You have significant difficulty reading or writing French - You are unable or unwilling to provide signed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERSalivary 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(12)

CHU de Caen

Caen, Calvados, France

CHU Angers

Angers, France

CH Bastia

Bastia, 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

CHRU Bretonneau-Tours

Tours, France

CHU Tenon

Paris, France

CHU Lyon Sud / Hospices Civils de Lyon

Lyon, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05514028


Related Trials