NCT05514028

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
746

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
3 countries

21 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
May 2022Apr 2027

Study Start

First participant enrolled

May 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

July 4, 2022

Last Update Submit

March 24, 2026

Conditions

Ovarian CancerOvarian Cyst BenignBorderline Ovarian Cancer

Keywords

CancerRNAmachine learning algorithmsOvarian

Outcome Measures

Primary Outcomes (1)

  • Area under the curve (AUC) of the Receiver Operating Curve (ROC)

    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

Study Arms (3)

Cyst Benign

400 patients

Other: Salivary samples

Ovarian Cancer

200 patients

Other: Salivary samples

Borderline Ovarian Cancer

60 patients

Other: Salivary samples

Interventions

Salivary samplesOTHER

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 CancerCyst BenignOvarian Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CHU de Caen

Caen, Calvados, 14000, France

Location

CGFL

Dijon, Côte d'Or, 21079, France

Location

Institut Bergonié

Bordeaux, Gironde, 33076, France

Location

CHU Strasbourg

Strasbourg, Haut-Rhin, 67200, France

Location

CHU Toulouse

Toulouse, Haute-Garonne, 31059, France

Location

CHP St Grégoire

Saint-Grégoire, Ille Et Villaine, 35760, France

Location

Hôpital BICETRE

Le Kremlin-Bicêtre, Val de Marne, 94275, France

Location

Institut Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

CHU Angers

Angers, 49933, France

Location

CH Bastia

Bastia, 20600, France

Location

CHU Lyon Sud / Hospices Civils de Lyon

Lyon, 69000, France

Location

Centre Antoine Lacassagne

Nice, France

Location

CH Niort

Niort, 79021, France

Location

CHU Tenon

Paris, 75020, France

Location

CHU Rennes

Rennes, 35000, France

Location

Clinique La sagesse

Rennes, France

Location

CHU Rouen, Hôpital de Bois-Guillaume

Rouen, France

Location

Clinique Pasteur

Toulouse, France

Location

CHRU Bretonneau-Tours

Tours, 37044, France

Location

Universitätsklinik für Frauenheilkunde

Bern, 03010, Switzerland

Location

Centre de Maternité et de Néonatologie Wassila Bourguiba

Tunis, 01007, Tunisia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

August 24, 2022

Study Start

May 4, 2022

Primary Completion

April 10, 2025

Study Completion (Estimated)

April 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

FR(19)CH(1)TU(1)