Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ZIWIG
- 入组人数
- 2,500
- 试验地点
- 13
- 主要终点
- Area under the curve (AUC) of the Receiver Operating Curve (ROC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
时间窗: 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.
次要结局
未报告次要终点