SERum-bank for PANcreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Serum adiponectin concentration
研究概览
简要总结
This study is about pancreatic cancer. If the diagnostic cancer is done at an early stage (<2cm), the chances of recovery are very good.
But the main problem is there is not any detections means for this cancer. Sadly, when there is a cancer diagnostic , it's already too late in the majority of cases, because the cancer is in an advanced case.
Today, there is no any effective means of detection... Blood markers can be a simple means of early detection
详细描述
The purpose of this study is to establish a sero-library in a case-control cohort to assess several potentially useful serum biomarkers, such as adiponectin in the early diagnosis of pancreatic cancer.
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
- 否
入选标准
- •Documented adenocarcinoma (cytology / anatomopathology), all stages, except if the tumor is immediately resectable and does not require preoperative cytological evidence. In this case, the inclusion and the first collection of the sero bank is done preoperatively. The diagnostic confirmation will therefore be made post-operatively at the risk of being excluded in the event of a different diagnosis.
- •At the start of treatment (before surgery / 1st course of chemotherapy)
- •Age ≥ 18 years
- •Patient affiliated or entitled to a social security system
排除标准
- •Patient refusal
- •Acute renal failure
- •Child-Pugh B or C cirrhosis
- •Patient under guardianship or curators
- •Other synchronous cancer or history of cancer <5 years
- •Language barrier
- •CONTROL GROUP
- •Inclusion Criteria:
- •Age ≥ 40 years
- •Patient affiliated or entitled to a social security system
- •Digestive endoscopy for any reason other than cancer or chronic inflammatory bowel disease
- •Exclusion Criteria:
- •Patient refusal
- •Acute renal failure
- •Child-Pugh B or C cirrhosis
- •Patient under guardianship or curators
- •Other synchronous cancer or history of cancer <5 years
研究组 & 干预措施
Adenocarcinoma group
Patients with Adenocarcinoma will be included. They will have blood sample at the inclusion visit and at 3 months, 6 months, 9 months and 12 months after.
干预措施: Blood sample (Biological)
Control group
Patient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit.
干预措施: Blood sample (Biological)
结局指标
主要结局
Serum adiponectin concentration
时间窗: Months : 0
Measure by blood sample result Serum adiponectin concentration threshold for which the specificity will be 100% for the diagnosis of pancreatic cancer with a sensitivity of 80%.
次要结局
- Overall survival(Months : 24)
- Serum CA19.9 concentration(Months : 0, 3, 6, 9, 12)
- Tumor response and progression rates according to RECIST v1.1(Month 12)
- Progression-free survival(Months : 24)
- Serum adiponectin concentration(Months : 3, 6, 9, 12)