Ovarian CancerOVAmiARNNCT05514028
Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin
An observational study of Ovarian Cancer and Ovarian Cyst Benign, run by ZIWIG at 21 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Cyst Benign, Borderline Ovarian Cancer
- What is being tested?
- Salivary samples
- How many people
- 746 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 4 May 2022to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI and/or blood tumour markers) and requiring surgical management in routine care. The patients concerned by the study already benefit from a surgical management in different gynecology-obstetrics/gynecological oncology departments in France, Canada and Tunisia, as well as from a validation of the therapeutic indications in accordance with the national practices in force. 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 and/or blood tumour markers) necessary according to the context which are carried out according to the national and/or international recommendations in force.
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
France19 sites
CHU Angers
Angers, 49933
CH Bastia
Bastia, 20600
Institut Bergonié
Bordeaux, Gironde, 33076
CHU de Caen
Caen, Calvados, 14000
CGFL
Dijon, Côte d'Or, 21079
Hôpital BICETRE
Le Kremlin-Bicêtre, Val de Marne, 94275
CHU Lyon Sud / Hospices Civils de Lyon
Lyon, 69000
Centre Antoine Lacassagne
Nice
CH Niort
Niort, 79021
CHU Tenon
Paris, 75020
CHU Rennes
Rennes, 35000
Clinique La sagesse
Rennes
CHU Rouen, Hôpital de Bois-Guillaume
Rouen
CHP St Grégoire
Saint-Grégoire, Ille Et Villaine, 35760
CHU Strasbourg
Strasbourg, Haut-Rhin, 67200
CHU Toulouse
Toulouse, Haute-Garonne, 31059
Clinique Pasteur
Toulouse
CHRU Bretonneau-Tours
Tours, 37044
Institut Gustave Roussy
Villejuif, Val de Marne, 94805
Tunisia1 site
Centre de Maternité et de Néonatologie Wassila Bourguiba
Tunis, 01007
About this study
Official title: Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin - OVAmiARN Study
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.
Read more
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
- Being tested
- Salivary samples
- Keywords
- Cancer, RNA, machine learning algorithms, Ovarian
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary samplesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Cyst Benign | 400 patients Receives: Other: Salivary samples | |
| Ovarian Cancer | 200 patients Receives: Other: Salivary samples | |
| Borderline Ovarian Cancer | 60 patients Receives: Other: Salivary samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through the end of study inclusions, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start4 May 2022
- Primary completion10 Apr 2025
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZIWIG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group, iGenSeq
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514028
- Sponsor's protocol ID
- FR-22-01
- Acronym
- OVAmiARN
- Status last verified
- Mar 2026
- First submitted
- 4 Jul 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin - OVAmiARN Study
- ClinicalTrials.gov ID
- NCT05514028
- Acronym / sponsor ID
- OVAmiARN / FR-22-01
- Keywords
- Cancer, RNA, machine learning algorithms, Ovarian
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 746 participants (actual)
- Lead sponsor
- ZIWIGIndustry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group, iGenSeq
- Study start
- 4 May 2022 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cyst Benign | – | Other: Salivary samples400 patients |
| Ovarian Cancer | – | Other: Salivary samples200 patients |
| Borderline Ovarian Cancer | – | Other: Salivary samples60 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI and/or blood tumour markers) and requiring surgical management in routine care. The patients concerned by the study already benefit from a surgical management in different gynecology-obstetrics/gynecological oncology departments in France, Canada and Tunisia, as well as from a validation of the therapeutic indications in accordance with the national practices in force. 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 and/or blood tumour markers) necessary according to the context which are carried out according to the national and/or international recommendations in force.
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary samplesFor 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) | Other | Borderline Ovarian Cancer, Cyst Benign, Ovarian Cancer |
Primary outcome
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
Time frame: Through the end of study inclusions, an average of 6 months
Identifying a signature of ovarian cancer diagnosis by analysis of coding and non-coding RNAs in the saliva of subjects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Ovarian Cyst Benign, run by ZIWIG at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Switzerland, Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of the Receiver Operating Curve (ROC) (time frame: Through the end of study inclusions, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.