Évaluation des ARN salivaires en présence d'une masse annexielle d'origine ovarienne

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : Étude observationnelle
Étape de prise en charge : Surveillance
Date d'ouverture : 01/01/2023
Date clôture : 31/12/2025
Promoteur : ZIWIG
Progression du cancer: Loco-régional
Résumé :

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

Domaines/spécialités :
  • Cancers gynécologiques
    • Ovaire
Pathologies :
  • Tumeur maligne de l'ovaire - Cim10 : C56
  • Tumeur bénigne de l'ovaire - Cim10 : D27
Liens externes :

Critères de population

Sexe : Femme
Age minimum : 18 ans
Critères d’inclusion :
  • 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,
Critères d’exclusion :
  • 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

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Dr COSTAZ
Prénom : Hélène
Téléphone : Non disponible
Email : hcostaz@cgfl.fr
CONTACT TECHNIQUE
Nom : LE BERRE
Prénom : Kevin
Téléphone : 03 80 73 77 51
Email : kleberre@cgfl.fr

Référentiels Oncologik

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