Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin - OVAmiARN Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ZIWIG
- 入组人数
- 250
- 试验地点
- 12
- 主要终点
- Area under the curve (AUC) of the Receiver Operating Curve (ROC)
研究概览
简要总结
OVAmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in 8 obstetrics and gynecology departments in France; in order to describe the evolution of salivary miRNA expression between the pre-operative and post-therapy visits according to the type of mass. In time, the clinical application will be to significantly reduce the time to diagnosis and improve the care pathway for ovarian adnexal mass.
The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI) and requiring surgical management in routine care.
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 (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.
In this study, the management and follow-up of patients :
- Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits,
- Are not modified in comparison with the usual follow-up, except for the performance of the Collection of saliva
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
- 否
入选标准
- •Patient over 18 years of age,
- •A patient with an ovarian adnexal mass diagnosed by clinical examination and imaging and likely to be ovarian cancer, a borderline tumour or a benign cyst,
- •Patient with an indication for surgery
- •Patient has dated and signed the consent form,
- •Patient affiliated to the healthcare system,
排除标准
- •Pregnant patient
- •Patient infected with human immunodeficiency virus (HIV),
- •Patient with significant difficulties in reading or writing the French language.
- •Patient with another diagnosed cancer
- •Patient with a history of cancer less than 5 years old
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 6 months
Identifying a signature of ovarian cancer diagnosis by analysis of coding and non-coding RNAs in the saliva of subjects
次要结局
未报告次要终点