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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05514028
Other study ID # FR-22-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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