Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 363
- 试验地点
- 2
- 主要终点
- For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).
研究概览
简要总结
This trial is a non-randomized, open label and multicenter study.
It aims to :
for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases for ovarian cancer : to validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (the investigators mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).
详细描述
MicroRNAs (miRs) have been linked to carcinogenesis and can act as metastatic activators or suppressors. There is now ample evidence that circulating miRs can be used as biomarkers. This project is focused on ovarian (OC) and endometrial cancers (EC), respectively the deadliest and most frequent gynecologic malignancies.
The main challenge for physicians managing women with early-stage EC is when to opt for lymphadenectomy. Tools that are currently used are not accurate enough to identify women with increased risk of nodal metastases. Ballester's team recently found a relationship between the high expression of a set of 5 miRs in the primary tumor and nodal status.
OC is the leading cause of death from gynecological cancer. The prognosis depends on the response of the residual tumor mass to adjuvant chemotherapy. Currently, this response remains largely unpredictable and even difficult to monitor with CA125 measurements and current imaging techniques. Busson's team recently showed that the variation of plasma miR200b during primary treatment is predictive of progression-free survival (PFS).
The study involves 3 populations of participants :
- Patients with EC
- Patients with OC
- Patients undergoing surgery for benign pelvic lesions (control population)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •For all patients (EC, OC, Control)
- •Written informed consent;
- •Age ≥ 18 years old;
- •Patient affiliated to social security.
- •EC patients
- •Histologically proven EC ;
- •Type 1 and 2 EC;
- •FIGO stage I or II or III EC requiring first intention surgical staging.
- •OC patients
- •Histologically proven OC or strong suspicion of OC on clinical arguments (abdomino-pelvian mass detected by palpation or echography and/or ascitis and/or elevated CA125);
- •Epithelial OC: any histological subtype;
- •FIGO stage I to IV OC.
- •Control patients - Any lesion which is supposed to be benign and requires surgery. -
排除标准
- •For all patients (OC, EC, Control)
- •Unable or unwilling to comply with the protocol requirements and/or unwilling to sign an informed consent form.
- •Deprived of liberty or under legal protection measure;
- •Ongoing pregnancy;
- •Control patients:
- •Previous history of cancer.
- •EC patients
- •FIGO stage IV at preoperative imaging techniques.
- •Previous history of cancer. OC patients
- •Non epithelial cancer.
- •Previous history of cancer - except for patients who developed breast cancer at least 5 years or more before ovarian cancer.
结局指标
主要结局
For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).
时间窗: 2 months
To validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases.
For OC: PFS or death for any cause at 24 months.
时间窗: 24 months
To validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (by OC treatment, we mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).
次要结局
- It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of OS in EC and OC(60 months)
- It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC (1)(2 months)
- It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of PFS in EC and OC(60 months)
- Sensitivity and specificity of plasma miR detection by RCA-FRET applied directly on plasma samples or following RNA extraction.(60 months)
- It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC.(2 months)