Clinical trial NCT05514028: Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin
Official title: Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin - OVAmiARN Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Ovarian Cyst Benign
Borderline Ovarian Cancer
Keywords: Cancer
RNA
machine learning algorithms
Ovarian
Lead sponsor: ZIWIG
Sponsor class: INDUSTRY
Collaborators: name: Monitoring Force Group
name: iGenSeq
First posted: 2022-08-24
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve (AUC) of the Receiver Operating Curve (ROC)
timeFrame: Through the end of study inclusions, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
state: Calvados
city: Angers
country: France
facility: CHU Angers
city: Bastia
country: France
facility: CH Bastia
city: Lyon
country: France
facility: CHU Lyon Sud / Hospices Civils de Lyon
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Niort
country: France
facility: CH Niort
city: Paris
country: France
facility: CHU Tenon
city: Rennes
country: France
facility: CHU Rennes
city: Rennes
country: France
facility: Clinique La sagesse
city: Rouen
country: France
facility: CHU Rouen, Hôpital de Bois-Guillaume
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU Bretonneau-Tours
Study officials:
References: