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NCT Number: NCT06392997

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
  • Subject with significant difficulties reading or writing her language
  • Subject unable to comply with study and/or follow-up procedures
  • Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.

Treatment and study plan

Saliva sample

Diagnostic Test

Saliva sample

Primary outcomes

  1. Area under the curve (AUC) of the Receiver Operating Curve (ROC)

    Time frame: Through the end of study inclusions, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sofiane Bendifallah, MD

CONTACT

[email protected]

+33146412699

Sponsors and collaborators

Lead sponsor

ZIWIG

Industry

Collaborators

  • Monitoring Force Group

Registry information

Acronym: GynRNA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 1, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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