Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology (GynRNA)

Ziwig

Status: Enrolling

Conditions: Uterine Cancer; Endometriosis; Gynecologic Cancer; Fibroid; Cyst Ovary; Gynecologic Disease; Ovarian Cancer; Cervical Cancer

Treatments: Diagnostic Test: Saliva sample

Study type: Observational

Funder types: Industry

Identifiers

NCT06392997

ZWG-24-01

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,500 participants in 2 patient groups

Symptomatic group

Description:

Clinically symptomatic females with one or more of the following gynecological pathology: * Endometriosis, * Adenomyosis, * Ovarian cysts, * Fibroids, * Ovarian cancer, * Cervical cancer * Uterine cancer.

Treatment:

Diagnostic Test: Saliva sample

Asymptomatic group

Description:

Asymptomatic females with: * Cervical dysplasia or cancer * A normal pap-smear (control)

Treatment:

Diagnostic Test: Saliva sample