Actively Recruiting
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Led by ZIWIG · Updated on 2025-01-23
2500
Participants Needed
13
Research Sites
103 weeks
Total Duration
On this page
Sponsors
Z
ZIWIG
Lead Sponsor
M
Monitoring Force Group
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 18 years or older
- Signed informed consent form by the subject or legal representative
- Medical insurance policy holder
- Presenting with symptoms (bleeding, pain, or clinical signs) of endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian cancer, cervical cancer, or uterine cancer and scheduled for diagnostic surgery or biopsy before any curative treatment
- Asymptomatic with a positive pap smear for cervical dysplasia or cervical cancer before any curative treatment
- Asymptomatic undergoing pap smear screening in a gynecological follow-up context
You will not qualify if you...
- Recent (less than 1 month) or ongoing bacterial or viral infection
- Known active oral or digestive fungal infection
- Ongoing symptomatic or evident oral disease
- Known pregnancy
- Known non-gynecological pelvic disease
- Diagnosis of breast cancer or non-gynecological cancer except basal cell carcinoma
- History of treated cancer within the last 5 years except basal cell carcinoma
- Previous chemotherapy, radiotherapy, or surgical removal of the gynecological pathology under study
- Significant difficulty reading or writing the language
- Unable to comply with study or follow-up procedures
- Participation in another interventional study with investigational drugs or within exclusion period of such study
AI-Screening
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Trial Site Locations
Total: 13 locations
1
CHU d'Angers
Angers, France
Not Yet Recruiting
2
Clinique Tivoli Ducos - IFEMENDO
Bordeaux, France
Actively Recruiting
3
Institut Bergonié
Bordeaux, France
Not Yet Recruiting
4
CHU Caen
Caen, France, 14033
Actively Recruiting
5
CGFL
Dijon, France
Not Yet Recruiting
6
CHU Lyon Sud
Lyon, France
Not Yet Recruiting
7
American Hospital of Paris
Neuilly-sur-Seine, France
Not Yet Recruiting
8
CHU de Rennes Site Hôpital Sud
Rennes, France
Not Yet Recruiting
9
Clinique La sagesse
Rennes, France
Not Yet Recruiting
10
CHU Rouen
Rouen, France
Actively Recruiting
11
Clinique Pasteur
Toulouse, France
Actively Recruiting
12
CHU Bretonneau-Tours
Tours, France
Actively Recruiting
13
Institut Gustave Roussy
Villejuif, France
Not Yet Recruiting
Research Team
S
Sofiane Bendifallah, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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