NCT05470738尚未招募不适用
PAncreas Borderline and Locally Advanced Snapshot Study
University Hospital, Clermont-Ferrand23 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2022年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 试验地点
- 23
- 主要终点
- The main study's objective is to definite the effective rate of adjuvant chemotherapy performed after surgery (at the 3-month post operatively), which is essential marker recognized as improving overall survival.
研究概览
简要总结
The project's objective is to carry out prospectively, in France, for one year, a descriptive registry study in the management of patients with borderline or locally advanced pancreatic adenocarcinoma, and to collect both the patient's demographic characteristics, but also the therapeutic regimens applied, the types of surgeries performed and the outcome of the patients after surgery, and at three months of follow up (preoperative data, complications's post surgery, quality of the resection, etc.)
详细描述
- Multicenter, observational prospective study over one year in France in patients with borderline or locally advanced pancreatic adenocarcinoma operated between September 2022 and August 2023.
- Patients will be screened by the pancreatic's surgeons practicing in a reference centers during preoperative surgical consultations (V1),
- The patient's non-objection will be sollected,
- The end of follow-up's patient will take place during the post-operative consultation approximately 3 months after surgery (V3)
- Between V1 and V3, preoperative data (demography, history, tumor characteristics, neoadjuvant treatments performed, tumor response), operative, intraoperative, pathological and postoperative data will be collected via a e-CRF " the REDCAP software".
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
- •Any patient over the age of 18, operated on for pancreatic adenocarcinoma, borderline or locally advanced, between September 2022 and August 2023, in France
- •Diagnosis of pancreatic adenocarcinoma:
- •either after cytopuncture with anatomopathological result confirming the diagnosis,
- •or with strong suspicion on the combined criterias : clinical, biological and morphological criterion (according to INCa 2019 and NCCN recommendations ) in the event of absence of anatomopathological documentation (failure of several fine needle punctures (maximum 3)/or non-contributory anatomopathological examinations),
- •Borderline or locally advanced character depending on the presence of a contact of the tumor with nearby vessels and defined by morphological examination (scanner +/- MRI). These criteria are defined by the NCCN Guidelines for Pancreatic Adenocarcinoma V.1.2021, international reference
排除标准
- •Patient under juridic protected or subject to any measure of legal protection,
- •Patients not operated on for their pancreatic adenocarcinoma,
- •Adenocarcinoma of the pancreas operable immediately on diagnosis,
- •Metastatic pancreatic adenocarcinoma from the outset on diagnosis,
- •Patient without pancreatic adenocarcinoma after histological examination (in the case where the pancreatic lesion was operated on for strong suspicion of pancreatic adenocarcinoma on the combined clinical, biological and morphological criterion (according to INCa 2019 and NCCN recommendations, but that the lesion on definitive pathological examination is not a pancreatic adenocarcinoma)
结局指标
主要结局
The main study's objective is to definite the effective rate of adjuvant chemotherapy performed after surgery (at the 3-month post operatively), which is essential marker recognized as improving overall survival.
时间窗: during 1 year
Evaluation of the rate of adjuvant chemotherapy performed after surgery (at the 3-month post operatively)
次要结局
- The secondary objective of the study is to know, in patients operated for pancreatic adenocarcinoma, the rate of postoperative complications, the rate of the postoperative morbidity and mortality, and the quality of the resection.(during 1 year)
研究者
研究点 (23)
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