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

Ovarian Cancer Clinical Trial

— GynRNA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392997
• Other study ID #: ZWG-24-01
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: ZIWIG
• Contact: Sofiane Bendifallah, MD
• Phone: +33146412699
• Email: sofiane.bendifallah[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Cyst Ovary
• Endometriosis
• Fibroid
• Genital Diseases, Female
• Gynecologic Cancer
• Gynecologic Disease
• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

Diagnostic Test:
• Saliva sample
Saliva sample

Locations

Country	Name	City	State
France	American Hospital of Paris	Neuilly-sur-Seine

Sponsors (2)

Lead Sponsor	Collaborator
ZIWIG	Monitoring Force Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through the end of study inclusions, an average of 1 year