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临床试验/NCT03293433
NCT03293433已完成不适用

Quantification of microRNAs in Diagnosis of Pulmonary Nodules: Reproducibility Analysis of Intra- and Inter-observer and Inter-laboratory: Project miR-Nod

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
34 micro RNA extraction as assessed by quantification of micro RNA with Real-Time Quantitative Reverse Transcription polymerase chain reaction

研究概览

简要总结

One of the main challenges of thoracic oncology lies in earlier diagnosis of lung cancer to improve survival rate, wich is about 15% at 5 years. This poor prognosis is often linked to late diagnosis. Efforts are being made worldwide to offer testing in patients at risk or earlier diagnosis of lung cancer in order to offer the patient curative treatments. Indeed, supported at the stage of nodule (less than 3 cm lesion), lung cancer is curable by surgery in 80% of patients. Nevertheless, there are many differential diagnoses and access to these lesions is often difficult and risky. In this context, the management of pulmonary nodules, which can be either benign lesions or beginners cancers, is a real challenge for pulmonologists and thoracic oncologists every day: it is important not to disregard a potentially operable nodule and avoiding offer patients invasive procedures for benign nodules. Indeed, many procedures (endoscopy, puncture under scanner, thoracotomy) are made to determine if suspicious nodules are benign or not. In the large National Lung Screening Trial, 28% of the procedures were associated with complications (including 11% classified severe and 16 deaths). It is therefore essential to develop non-invasive tools to refine treatment decisions.

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
All
接受健康志愿者

入选标准

  • Patients with suspected abnormal chest X-ray image of malignancy defined by one solitary pulmonary nodule (NPS) NPS or 2 if operable, higher than 5 mm and less to 30 mm, without histological evidence.
  • Affiliation to social security.
  • Signature of informed consent.

排除标准

  • Nodule not accessible to curative local therapy (surgery, thermoablation, radiotherapy).
  • Patients in whom resection for diagnostic purposes this emergency such as one of these characters can not be delayed (these patients are not likely to belong to the people that can take a dosage of clinical interest miRNAs because the characteristics radiographic their nodule only tell them a high probability of lung cancer)
  • History of an unhealed cancer
  • Patients benefiting from a system of legal protection

结局指标

主要结局

34 micro RNA extraction as assessed by quantification of micro RNA with Real-Time Quantitative Reverse Transcription polymerase chain reaction

时间窗: Through the completion of study (18 months)

次要结局

  • Measure the inter-observer reproducibility as assessed by quantification of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction(Through the completion of study (18 months))
  • Measure the inter-laboratory reproducibility as assessed by rate of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction(Through the completion of study (18 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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