Gynecologic DiseaseGynRNANCT06392997
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
An observational study of Gynecologic Disease and Gynecologic Cancer, run by ZIWIG at 13 sites in France.
Trial summary
GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Disease, Gynecologic Cancer, Endometriosis
- What is being tested?
- Saliva sample
- How many people
- 2,500 participants
- Where
- 13 sitesFrance
- Study dates
- 5 Dec 2024to Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study populations is constituted of s: 1. Clinically symptomatic females with one or more of the following gynecological pathology: * Endometriosis, * Adenomyosis, * Ovarian cysts, * Fibroids, * Ovarian cancer, * Cervical cancer * Uterine cancer. 2. Asymptomatic females with: * cervical dysplasia or cancer * a normal pap-smear (control)
Who may be able to join
- Subject of legal age (according to local legislation) and at least 18 years old
- Subject (and if applicable her legal representative) having dated and signed the informed consent form
- Subject with a medical insurance policy
- Subject presenting to the department:
- With Symptoms (bleeding and/or pain and/or clinically observed symptom) of one or more of the following pathologies (suspected undergoing diagnostic surgery/biopsy or diagnosed and before any curative treatment of the pathology):
- Endometriosis
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- Adenomyosis,
- Ovarian cysts,
- Fibroids,
- Ovarian cancer,
- Cervical cancer,
- Uterine cancer.
- Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.
- Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context.
Who cannot join
- Recent (<1 month) or ongoing bacterial or viral infection
- Known active oral or digestive mycosis
- Evolving oral pathology, symptomatic or obvious
- Known pregnancy
- Known current non-gynecological pelvic pathology
- Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma
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- Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma
- Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
- Subject with significant difficulties reading or writing her language
- Subject unable to comply with study and/or follow-up procedures
- Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Not yet recruiting
CHU d'Angers
Angers
Léa DELBOS, Dr, +33 2 41 76 28 62, lea.delbos@chu-angers.fr
- Recruiting
Clinique Tivoli Ducos - IFEMENDO
Bordeaux
Horace ROMAN, Pr, +33 5 64 10 09 45, horace.roman@gmail.com
- Not yet recruiting
Institut Bergonié
Bordeaux
Frédéric GUYON, Dr, +33 5 56 33 32 79, f.guyon@bordeaux.unicancer.fr
- Recruiting
CHU Caen
Caen, 14033
Raffaèle Fauvet, Pr, +33 2 31 27 23 36, fauvet-r@chu-caen.fr
- Not yet recruiting
CGFL
Dijon
Hélène COSTAZ, Dr, +33 6 66 35 55 33, hcostaz@cgfl.fr
- Not yet recruiting
CHU Lyon Sud
Lyon
François GOLFIER, Pr, +33 4 78 86 41 78, françois.golfier@chu-lyon.fr
- Not yet recruiting
American Hospital of Paris
Neuilly-sur-Seine
Sofiane Bendifallah, MD, +33146412699, sofiane.bendifallah@yahoo.fr
- Not yet recruiting
CHU de Rennes Site Hôpital Sud
Rennes
Vincent LAVOUE, Pr, +33 2 99 28 43 21, vincent.lavoue@chu-rennes.fr
- Not yet recruiting
Clinique La sagesse
Rennes
Claire Marie ROGER, Dr, +33 2 99 85 75 14, cmroger@lasagesse.fr
- Recruiting
CHU Rouen
Rouen
Morgane PERRIN, Dr, +33 2 32 88 89 90, Morganeperrin.mp@gmail.com
- Recruiting
Clinique Pasteur
Toulouse
Ludivine Genre, Dr, +33 5 62 21 39 49, lgenre@clinique-pasteur.com
- Recruiting
CHU Bretonneau-Tours
Tours
Lobna OULDAMER, Pr, +33 2 47 47 47 41, l.ouldamer@chu-tours.fr
- Not yet recruiting
Institut Gustave Roussy
Villejuif
Alexandra LEARY, Dr, +33 1 42 11 43 77, alexandra.leary@gustaveroussy.fr
About this study
GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva.
The study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian/cervical/uterine cancer) and asymptomatic females.
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 necessary according to the context, which are carried out according to the local recommendations.
- Conditions
- Gynecologic Disease, Gynecologic Cancer, Endometriosis, Ovarian Cancer, Cyst Ovary, Fibroid
- Being tested
- Saliva sample
- Medical subject headings
- Genital Diseases, Female, Endometriosis, Ovarian Neoplasms, Ovarian Cysts, Leiomyoma, Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva sampleDiagnostic test
Saliva sample
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic group | Clinically symptomatic females with one or more of the following gynecological pathology:
* Endometriosis,
* Adenomyosis,
* Ovarian cysts,
* Fibroids,
* Ovarian cancer,
* Cervical cancer
* Uterine cancer. Receives: Diagnostic Test: Saliva sample | |
| Asymptomatic group | Asymptomatic females with:
* Cervical dysplasia or cancer
* A normal pap-smear (control) Receives: Diagnostic Test: Saliva sample |
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)
Identify a diagnostic signature for each pathology (Endometriosis / Adenomyosis / Ovarian cysts / Fibroids / Cervical Displasia / Ovarian cancer / Cervical cancer /Uterine cancer) by analyzing of coding and non-coding RNA contained in the saliva.
Measured: Through the end of study inclusions, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start5 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZIWIG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392997
- Sponsor's protocol ID
- ZWG-24-01
- Acronym
- GynRNA
- Status last verified
- Jan 2025
- First submitted
- 9 Apr 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
- ClinicalTrials.gov ID
- NCT06392997
- Acronym / sponsor ID
- GynRNA / ZWG-24-01
- Conditions
- Gynecologic Disease, Gynecologic Cancer, Endometriosis, Ovarian Cancer, Cyst Ovary, Fibroid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- ZIWIGIndustry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 May 2024 (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.
GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva.
The study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian/cervical/uterine cancer) and asymptomatic females.
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 necessary according to the context, which are carried out according to the local recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic group | – | Diagnostic Test: Saliva sampleClinically symptomatic females with one or more of the following gynecological pathology: * Endometriosis, * Adenomyosis, * Ovarian cysts, * Fibroids, * Ovarian cancer, * Cervical cancer * Uterine cancer. |
| Asymptomatic group | – | Diagnostic Test: Saliva sampleAsymptomatic females with: * Cervical dysplasia or cancer * A normal pap-smear (control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study populations is constituted of s: 1. Clinically symptomatic females with one or more of the following gynecological pathology: * Endometriosis, * Adenomyosis, * Ovarian cysts, * Fibroids, * Ovarian cancer, * Cervical cancer * Uterine cancer. 2. Asymptomatic females with: * cervical dysplasia or cancer * a normal pap-smear (control)
Key inclusion criteria (14 listed)
- Subject of legal age (according to local legislation) and at least 18 years old
- Subject (and if applicable her legal representative) having dated and signed the informed consent form
- Subject with a medical insurance policy
- Subject presenting to the department:
Key exclusion criteria (11 listed)
- Recent (<1 month) or ongoing bacterial or viral infection
- Known active oral or digestive mycosis
- Evolving oral pathology, symptomatic or obvious
- Known pregnancy
- Known current non-gynecological pelvic pathology
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 |
|---|---|---|
| Saliva sampleSaliva sample | Diagnostic test | Asymptomatic group, Symptomatic group |
Primary outcome
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
Time frame: Through the end of study inclusions, an average of 1 year
Identify a diagnostic signature for each pathology (Endometriosis / Adenomyosis / Ovarian cysts / Fibroids / Cervical Displasia / Ovarian cancer / Cervical cancer /Uterine cancer) by analyzing of coding and non-coding RNA contained in the saliva.
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 23 Jan 2025.
- Individual participant dataSharing planned: No
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Disease and Gynecologic Cancer, run by ZIWIG at 13 sites in France.
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 14 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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?
Contact Sofiane Bendifallah, MD (+33146412699, sofiane.bendifallah@yahoo.fr), or a site near the patient. 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 1 year). 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 23 Jan 2025.