Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
GynRNA
1 other identifier
observational
2,500
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2024
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
December 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 23, 2025
January 1, 2025
2 years
April 9, 2024
January 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Asymptomatic group
Asymptomatic females with: * Cervical dysplasia or cancer * A normal pap-smear (control)
Interventions
Eligibility Criteria
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)
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
- Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma
- Subject with significant difficulties reading or writing her language
- Subject unable to comply with study and/or follow-up procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZIWIGlead
- Monitoring Force Groupcollaborator
Study Sites (13)
CHU d'Angers
Angers, France
Clinique Tivoli Ducos - IFEMENDO
Bordeaux, France
Institut Bergonié
Bordeaux, France
CHU Caen
Caen, 14033, France
CGFL
Dijon, France
CHU Lyon Sud
Lyon, France
American Hospital of Paris
Neuilly-sur-Seine, France
CHU de Rennes Site Hôpital Sud
Rennes, France
Clinique La sagesse
Rennes, France
CHU Rouen
Rouen, France
Clinique Pasteur
Toulouse, France
CHU Bretonneau-Tours
Tours, France
Institut Gustave Roussy
Villejuif, France
Biospecimen
Salivary samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2024
First Posted
May 1, 2024
Study Start
December 5, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 23, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share