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
N/A
Total Duration
On this page
Sponsors
Z
ZIWIG
Lead Sponsor
M
Monitoring Force Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an international non-interventional study to identify diagnostic markers for gynecological diseases by analyzing coding and non-coding RNA in saliva samples. The study focuses on symptomatic females with gynecological conditions such as endometriosis, adenomyosis, ovarian cysts, fibroids, and gynecological cancers, as well as asymptomatic females. Participants will continue their usual medical care without changes to treatment or diagnostic procedures. Participants are grouped into symptomatic females who have one or more specified gynecological pathologies and asymptomatic females either with cervical dysplasia or cancer or with normal pap-smears as controls. The study involves collecting saliva samples to analyze RNA content as a diagnostic tool. Patients will undergo their planned surgeries or biopsies according to standard care. During the study, participants will provide saliva samples and have their clinical status recorded. Researchers will measure the diagnostic accuracy of RNA markers by evaluating the area under the curve (AUC) of a receiver operating characteristic (ROC) curve over about one year. No additional treatment changes or interventions will be made. The total participation duration depends on the timing of scheduled surgeries and follow-ups.
CONDITIONS
Brief 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 aged 18 years or older
- Signed informed consent
- Has medical insurance
- Symptomatic with one or more of: endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian cancer, cervical cancer, uterine cancer and scheduled for diagnostic surgery or biopsy
- Asymptomatic with positive pap smear for cervical dysplasia or cervical cancer before treatment
- Asymptomatic undergoing pap smear for cervical cancer screening
You will not qualify if you...
- Recent (less than 1 month) or ongoing bacterial or viral infection
- Active oral or digestive fungal infection
- Current symptomatic or obvious oral disease
- Known pregnancy
- Known current non-gynecological pelvic pathology
- Diagnosed breast cancer or non-gynecological cancer except basal cell carcinoma
- History of treated cancer within last 5 years except basal cell carcinoma
- Prior chemotherapy, radiotherapy, or surgery for the gynecological pathology included
- Significant difficulties reading or writing the language
- Unable to comply with study or follow-up procedures
- Participation in another interventional study or within exclusion period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants provide saliva samples to evaluate salivary RNA related to gynecologic pathology before surgery or biopsy.
1 or more visits depending on group assignment
Duration - Up to 1 week
Participants undergo diagnostic surgery or biopsy for their gynecologic pathology as part of routine care.
1 surgical procedure with immediate post-operative care
Duration - Up to 1 year
Participants are observed for outcomes related to their gynecologic condition after surgery or biopsy, including follow-up saliva sample assessments.
Periodic follow-up visits over the year
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
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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