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

March 24, 2026 updated by: ZIWIG

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Other: Salivary samples

Study Type

Observational

Enrollment (Actual)

746

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Angers, France, 49933
    - CHU Angers
  - Bastia, France, 20600
    - CH Bastia
  - Lyon, France, 69000
    - CHU Lyon Sud / Hospices Civils de Lyon
  - Nice, France
    - Centre Antoine Lacassagne
  - Niort, France, 79021
    - CH NIORT
  - Paris, France, 75020
    - CHU Tenon
  - Rennes, France, 35000
    - CHU Rennes
  - Rennes, France
    - Clinique La sagesse
  - Rouen, France
    - CHU Rouen, Hôpital de Bois-Guillaume
  - Toulouse, France
    - Clinique Pasteur
  - Tours, France, 37044
    - CHRU Bretonneau-Tours
- Calvados
  - Caen, Calvados, France, 14000
    - CHU de Caen
- Côte d'Or
  - Dijon, Côte d'Or, France, 21079
    - CGFL
- Gironde
  - Bordeaux, Gironde, France, 33076
    - Institut Bergonie
- Haut-Rhin
  - Strasbourg, Haut-Rhin, France, 67200
    - CHU Strasbourg
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31059
    - Chu Toulouse
- Ille Et Villaine
  - Saint-Grégoire, Ille Et Villaine, France, 35760
    - CHP St Grégoire
- Val de Marne
  - Le Kremlin-Bicêtre, Val de Marne, France, 94275
    - Hôpital Bicêtre
  - Villejuif, Val de Marne, France, 94805
    - Institut Gustave Roussy
Switzerland
- - Bern, Switzerland, 03010
    - Universitätsklinik für Frauenheilkunde
Tunisia
- - Tunis, Tunisia, 01007
    - Centre de Maternité et de Néonatologie Wassila Bourguiba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI and/or blood tumour markers) and requiring surgical management in routine care.

The patients concerned by the study already benefit from a surgical management in different gynecology-obstetrics/gynecological oncology departments in France, Canada and Tunisia, as well as from a validation of the therapeutic indications in accordance with the national practices in force.

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 and/or blood tumour markers) necessary according to the context which are carried out according to the national and/or international recommendations in force.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cyst Benign 400 patients	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)
Ovarian Cancer 200 patients	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)
Borderline Ovarian Cancer 60 patients	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC) of the Receiver Operating Curve (ROC) Time Frame: 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	Through the end of study inclusions, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZIWIG

Collaborators

Monitoring Force Group

iGenSeq

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2022

Primary Completion (Actual)

April 10, 2025

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

FR-22-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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