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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Ovarian Cancer Adnexal Diseases Borderline Ovarian Cancer Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cyst Benign Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Caen, Caen, Calvados, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salivary samples

Other

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)

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

ZIWIG

Industry

Collaborators

Monitoring Force Group
iGenSeq

Registry information

Official study title

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

Acronym: OVAmiARN

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2027
First posted: Aug 24, 2022
Registry last updated: Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting