Clinical trial NCT06392997: Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Official title: Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecologic Disease
Gynecologic Cancer
Endometriosis
Ovarian Cancer
Cyst Ovary
Fibroid
Cervical Cancer
Uterine Cancer
Lead sponsor: ZIWIG
Sponsor class: INDUSTRY
Collaborators: name: Monitoring Force Group
First posted: 2024-05-01
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Subject of legal age (according to local legislation) and at least 18 years old
2. Subject (and if applicable her legal representative) having dated and signed the informed consent form
3. Subject with a medical insurance policy
4. Subject presenting to the department:

   1. 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
      * Adenomyosis,
      * Ovarian cysts,
      * Fibroids,
      * Ovarian cancer,
      * Cervical cancer,
      * Uterine cancer.
   2. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.
   3. Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context.

Exclusion Criteria:

1. Recent (\<1 month) or ongoing bacterial or viral infection
2. Known active oral or digestive mycosis
3. Evolving oral pathology, symptomatic or obvious
4. Known pregnancy
5. Known current non-gynecological pelvic pathology
6. Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma
7. Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma
8. Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
9. Subject with significant difficulties reading or writing her language
10. Subject unable to comply with study and/or follow-up procedures
11. Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.

Primary outcomes:
measure: Area under the curve (AUC) of the Receiver Operating Curve (ROC)
timeFrame: Through the end of study inclusions, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: Clinique Tivoli Ducos - IFEMENDO
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: CHU Caen
city: Dijon
country: France
facility: CGFL
city: Lyon
country: France
facility: CHU Lyon Sud
city: Neuilly-sur-Seine
country: France
facility: American Hospital of Paris
city: Rennes
country: France
facility: CHU de Rennes Site Hôpital Sud
city: Rennes
country: France
facility: Clinique La sagesse
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHU Bretonneau-Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: