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

Ziwig

Status

Enrolling

Conditions

Ovarian Cyst Benign

Ovarian Cancer

Borderline Ovarian Cancer

Treatments

Other: Salivary samples

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT05514028

FR-22-01

Details and patient eligibility

About

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

Enrollment

250 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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