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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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,

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CH Bastia
RECRUITING
Bastia
CHU de Caen
RECRUITING
Caen
CHU Lyon Sud / Hospices Civils de Lyon
RECRUITING
Lyon
Centre Antoine Lacassagne
RECRUITING
Nice
CH Niort
RECRUITING
Niort
CHU Tenon
RECRUITING
Paris
CHU Rennes
RECRUITING
Rennes
Clinique La sagesse
RECRUITING
Rennes
CHU Rouen, Hôpital de Bois-Guillaume
RECRUITING
Rouen
Clinique Pasteur
RECRUITING
Toulouse
CHRU Bretonneau-Tours
RECRUITING
Tours
Time Frame
Start Date: 2022-05-04
Estimated Completion Date: 2026-04
Participants
Target number of participants: 250
Treatments
Cyst Benign
100 patients
Ovarian Cancer
120 patients
Borderline Ovarian Cancer
30 patients
Related Therapeutic Areas
Sponsors
Collaborators: Monitoring Force Group, iGenSeq
Leads: ZIWIG

This content was sourced from clinicaltrials.gov