Evaluating salivary RNAs in patients with ovarian masses
Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin - OVAmiARN Study
This study is testing if changes in saliva can help doctors diagnose and manage patients with ovarian masses, including cancer, before and after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ziwig Industry-sponsored |
| Locations | 12 sites (Caen, Calvados and 11 other locations) |
| Trial ID | NCT05514028 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the changes in salivary microRNA expression in patients diagnosed with ovarian adnexal masses, including ovarian cancer, borderline tumors, and benign cysts. Conducted across multiple obstetrics and gynecology departments in France, the study will track these changes from pre-operative to post-therapy visits without altering the standard care pathway. The goal is to enhance diagnostic speed and improve patient management for those requiring surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with an ovarian adnexal mass diagnosed through clinical examination and imaging, who are scheduled for surgery.
Not a fit: Patients who are pregnant, have significant reading or writing difficulties in French, or have other diagnosed cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster diagnoses and better management strategies for patients with ovarian masses.
How similar studies have performed: While this approach is innovative in its focus on salivary RNAs for ovarian masses, similar studies using biomarkers for cancer diagnosis have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Caen, Calvados and 11 other locations
- CHU de Caen — Caen, Calvados, France (Recruiting)
- CHU Angers — Angers, France (Recruiting)
- CH Bastia — Bastia, France (Recruiting)
- CHU Lyon Sud / Hospices Civils de Lyon — Lyon, France (Recruiting)
- Centre Antoine Lacassagne — Nice, France (Recruiting)
- CH Niort — Niort, France (Recruiting)
- CHU Tenon — Paris, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- Clinique La sagesse — Rennes, France (Recruiting)
- CHU Rouen, Hôpital de Bois-Guillaume — Rouen, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- CHRU Bretonneau-Tours — Tours, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.