Convertases and Pancreatic Cancer. New Therapeutic and Prognostic Approach: Cohort of Patients Treated for Pancreatic Adenocarcinoma (CONVERCAP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation coefficients between level of expression of various convertases on the tumor and immune infiltrate
研究概览
简要总结
This is a prospective, single-centre, observational study. The analysis of samples of pancreatic tumours and/or metastases taken during biopsy or surgery will lead to the determination of the level of expression of convertases in patients with pancreatic cancer and could be used as an additional prognostic means reinforcing those currently used.
详细描述
After checking the inclusion criteria and signing the consent form, patients will be pre-selected for the study.
A tumour sample (primary tumour or metastasis) will be taken either during a biopsy or during pancreatic or metastasis surgery.
A blood sample will be taken on the same day as the tumour sample. The inclusion visit will be carried out by the investigating physician and will correspond to the visit when the results of the biopsy or surgery are reported.
Inclusion of the patient will be possible if the tumour sample has been taken, is available, contributory and malignant (diagnosis or confirmation of pancreatic adenocarcinoma) and if the blood sample has been taken and is available.
The patient will be considered to have failed pre-selection if
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
- •Age ≥ 18 years.
- •Pancreatic adenocarcinoma (suspected on radiological assessment or histologically proven):
- •Indication for biopsy of metastasis(es) performed as part of standard care for patients who already have a histologically confirmed diagnosis of pancreatic cancer.
- •Indication for pancreatic surgery or metastasis(es) carried out as part of standard care for patients with a suspicion of pancreatic cancer on radiological assessment or who already have a confirmed histological diagnosis of pancreatic cancer.
- •Whatever the stage of the disease.
- •Whatever the type of treatment proposed (systemic, surgery, radiotherapy, etc.).
- •Patient who has never received systemic treatment or advanced radiotherapy.
- •Life expectancy > 3 months.
- •Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- •Patient affiliated to a social security scheme in compliance with Article 1121-11 of the French Public Health Code.
排除标准
- •Indication for biopsy for primary diagnosis of pancreatic cancer
- •No indication for treatment of pancreatic cancer.
- •Adjuvant/neoadjuvant chemotherapy completed less than 6 months ago in the case of patients with recurrent disease.
- •Patient already included in the study.
- •Geographical, social or psychological factors rendering the patient unable to undergo study monitoring and procedures.
研究组 & 干预措施
CONVERCAP patients
The tumour sample (primary tumour or metastasis) will be taken either during a standard biopsy or during pancreatic or metastasis standard surgery.
Biopsy sampling of metastases is only authorised if the primary histological diagnosis of pancreatic adenocarcinoma has already been proven. If the patient has undergone a biopsy for diagnostic purposes, he/she cannot be included in the study.
The blood sample will be taken on the same day as the tumour sample.
干预措施: Blood sample (Other)
结局指标
主要结局
Correlation coefficients between level of expression of various convertases on the tumor and immune infiltrate
时间窗: Inclusion, Day 1
The level of expression of convertase proteins and their substrates (VEGF-C, IGF-1) will be determined on tumor samples at inclusion (healthy tissues, primary cancers and metastases), using qRT-PCR, western blot, ELISA, FACs and/or immunofluorescence as methodology and will be correlated with the following immune parameters, determined by immunofluorescence (including but not limited to): CD8, CD4, NK,Tregs, Macrophages The analysis will assess the correlation between the expression of various convertases on the tumor and immune parameters using Pearson's correlation coefficient for normally distributed variables, or Spearman's correlation coefficient for non-normally distributed variables. The correlation coefficient ranges from -1 to 1: a value closer to 1 indicates a strong positive association, a value closer to -1 indicates a strong negative association, and a value closer to 0 indicates no association.
次要结局
- Correlation coefficients between level of expression of various convertases determined at plasma level and immune infiltrate(Inclusion, Day 1)