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NCT06392997Recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2500 (estimated)
First submitted
9 Apr 2024
Start date
5 Dec 2024
Primary completion date
Dec 2026
Lead sponsor
ZIWIG
NCT number
NCT06392997

What you commit to

  • Study type: Observational
  • Planned participants: 2500
  • From 5 Dec 2024 to the primary completion date, Dec 2026
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
  • Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.

Other illness

  • Recent (\<1 month) or ongoing bacterial or viral infection
  • 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

Other

  • Known active oral or digestive mycosis
  • Evolving oral pathology, symptomatic or obvious
  • Known pregnancy
  • Known current non-gynecological pelvic pathology
  • Subject with significant difficulties reading or writing her language
  • Subject unable to comply with study and/or follow-up procedures

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU d Angers
Coordinator of this site? Confirm its status
AngersFranceNot yet recruiting
Institut Bergonie
Coordinator of this site? Confirm its status
BordeauxFranceNot yet recruiting
Clinique Tivoli Ducos - IFEMENDO
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceRecruiting
CGFL
Coordinator of this site? Confirm its status
DijonFranceNot yet recruiting
CHU Lyon Sud
Coordinator of this site? Confirm its status
LyonFranceNot yet recruiting
American Hospital of Paris
Coordinator of this site? Confirm its status
Neuilly-sur-SeineFranceNot yet recruiting
Clinique La sagesse
Coordinator of this site? Confirm its status
RennesFranceNot yet recruiting
CHU de Rennes Site Hôpital Sud
Coordinator of this site? Confirm its status
RennesFranceNot yet recruiting
CHU Rouen
Coordinator of this site? Confirm its status
RouenFranceRecruiting
Clinique Pasteur
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
CHU Bretonneau-Tours
Coordinator of this site? Confirm its status
ToursFranceRecruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.