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

Ovarian Cancer Clinical Trial

— OVAmiARN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514028
• Other study ID #: FR-22-01
• Status: Recruiting
• Start date: May 4, 2022
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: ZIWIG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Cyst Benign
• Ovarian Cysts
• Ovarian Neoplasms

Intervention

Other:
• Salivary samples
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)

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CH Bastia	Bastia
France	CHU de Caen	Caen	Calvados
France	CHU Lyon Sud / Hospices Civils de Lyon	Lyon
France	Centre Antoine Lacassagne	Nice
France	CH Niort	Niort
France	CHU Tenon	Paris
France	CHU Rennes	Rennes
France	Clinique La sagesse	Rennes
France	CHU Rouen, Hôpital de Bois-Guillaume	Rouen
France	Clinique Pasteur	Toulouse
France	CHRU Bretonneau-Tours	Tours

Sponsors (3)

Lead Sponsor	Collaborator
ZIWIG	iGenSeq, Monitoring Force Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of the Receiver Operating Curve (ROC)	Identifying a signature of ovarian cancer diagnosis by analysis of coding and non-coding RNAs in the saliva of subjects	Through the end of study inclusions, an average of 6 months