Role of the Protozoa Cryptosporidium in the Development of Colorectal Cancer in Humans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Prevalence of Cryptosporidium
研究概览
简要总结
It has been reported that Cryptosporidium parvum, a species of a protozoan frequently isolated from humans and animals, is able to induce digestive adenocarcinoma in a rodent model. Consistently, some epidemiological studies have reported an association with cryptosporidiosis in patients with colorectal adenocarcinoma. However, the correlation between cryptosporidiosis and human digestive cancer remains unclear at this time, and it is not known whether this intracellular parasite, considered an opportunistic agent, is able to induce gastrointestinal malignancies in humans. In order to add new arguments for a probable association between cryptosporidiosis and digestive human cancer, the main aim of this study is to determine prevalence and to identify species of Cryptosporidium among a French digestive cancer population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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 old
- •Patients with colonic adenocarcinoma/intraepithelial neoplasia diagnosed prior to chemotherapy or radiotherapy who will undergo scheduled surgery. Patients with rectal cancer with indication for neoadjuvant treatment will still be included, but only biopsies used for diagnosis will be used
- •Patient capable of receiving informed information
- •Written informed consent
- •Affiliation to a social security scheme
- •Age ≥ 18 years old
- •Patients with endoscopic indication for benign pathology
- •Patients with indication for colectomy for benign pathology
- •Patients with digestive cancer (stomach, oesophagus, biliary, pancreatic, etc.) of any type other than colorectal cancer before chemotherapy or radiotherapy
- •Patient capable of receiving informed information
- •Written informed consent
- •Affiliation to a social security scheme
排除标准
- •Patients undergoing pre-operative chemotherapy.
- •Patients who have already had chemotherapy for less than one year or other immunosuppressive treatment
结局指标
主要结局
Prevalence of Cryptosporidium
时间窗: 3 years
A biopsy or a surgical sample will be collected from every participant which will be then screened for Cryptosporidium using a Polymerase chain reaction (PCR) in order to obtain a prevalence of positive individuals
次要结局
- Significance of the association between the histological grade of the lesion and the parasitic charge in tissues(3 years)
- The rate of change in the expression or localization of certain markers known or suspected to be involved in the process of carcinogenesis.(3years)
- Rate of development of a neoplastic lesion in the human explants(3 years)
- Rate of occurrence of parasite development in the tumoral zone (yes/no) compared to the peri-tumoral zone.(3 years)
- Significance of the association between the histological grade of the lesion and the Cryptosporidium species(3 years)
- The association between the rate of lymphocytes (CD3, CD4, CD8, CD19 and CD4/CD8 ratio) and the presence of parasites in biopsies or surgical specimens(3 years)