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临床试验/NCT02072616
NCT02072616终止不适用

Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2014年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
101
试验地点
1
主要终点
sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma

研究概览

简要总结

Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).

Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).

The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patient is male or female, and > 18 years of age
  • Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
  • Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
  • Patient has agree to participate by giving written informed consent

排除标准

  • metastatic pancreatic tumor
  • cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
  • minor patient under 18 years
  • contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
  • patient under guardianship
  • Pregnant or lactating women

研究组 & 干预措施

Sample for Circulating Tumoral Cells

Experimental

Sampling of Circulating Tumoral Cells will be done after Pancreatic adenocarcinoma diagnosis

干预措施: Pancreatic adenocarcinoma diagnosis (Other)

结局指标

主要结局

sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma

时间窗: Day 1

Ratio between the numbers of patients for which CTCs were observed and patients with pancreatic adenocarcinoma confirmed by pathology (FNA OR surgical specimen)

次要结局

  • diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma(Day 1)
  • Time to first recurrence or death(Month 18)
  • prognostic impact of circulating tumor cells and / or circulating tumor DNA (KRAS) and / or CA19.9(Day 1)
  • Time to first recurrence or death(Month 36)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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