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

Launched by ZIWIG · Apr 25, 2024

Keywords

ClinConnect Summary

The GynRAN clinical trial is studying how analyzing RNA (a type of genetic material) found in saliva can help diagnose various gynecological conditions, including endometriosis, ovarian cancer, and fibroids. This research aims to identify specific patterns in the RNA that can indicate these diseases, which could lead to better diagnostic methods in the future. The trial is open to women aged 18 and older who are experiencing symptoms of these conditions or who are asymptomatic but are undergoing routine cervical cancer screenings.

Participants in this study will not have their usual medical care changed; they will continue to receive the standard treatments and follow-up exams as recommended by their healthcare providers. To be eligible, women must have a medical insurance policy and must provide signed consent to participate. However, those with certain active infections, other significant health issues, or recent cancer treatments will not be able to join. This study is currently recruiting participants and is a valuable opportunity to contribute to research that could improve gynecological healthcare.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject of legal age (according to local legislation) and at least 18 years old
• • 2. Subject (and if applicable her legal representative) having dated and signed the informed consent form
• • 3. Subject with a medical insurance policy
• 4. Subject presenting to the department:
• 1. 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.
• • 2. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.
• • 3. Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context.
• Exclusion Criteria:
• • 1. Recent (\<1 month) or ongoing bacterial or viral infection
• • 2. Known active oral or digestive mycosis
• • 3. Evolving oral pathology, symptomatic or obvious
• • 4. Known pregnancy
• • 5. Known current non-gynecological pelvic pathology
• • 6. Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma
• • 7. Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma
• • 8. Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
• • 9. Subject with significant difficulties reading or writing her language
• • 10. Subject unable to comply with study and/or follow-up procedures
• • 11. Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.