Cryptosporidium Infection and Human Colorectal Cancer
- Conditions
- Colonic NeoplasmsCryptosporidiosis
- Interventions
- Diagnostic Test: Detection of Cryptosporidium infection
- Registration Number
- NCT04332705
- Lead Sponsor
- Lille Catholic University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 324
Cases:
- 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
Controls:
- 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
- Patients undergoing pre-operative chemotherapy.
- Patients who have already had chemotherapy for less than one year or other immunosuppressive treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with colon cancer Detection of Cryptosporidium infection Patients with colon cancer of recent diagnosis will be recruited in consultation either in the surgical or gastroenterology departments Patients without colon cancer Detection of Cryptosporidium infection Patients without colon cancer but with other gastrointestinal pathology needing a biopsy or a surgical procedure will be recruited either in the surgical or gastroenterology departments
- Primary Outcome Measures
Name Time Method Prevalence of Cryptosporidium 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
- Secondary Outcome Measures
Name Time Method Significance of the association between the histological grade of the lesion and the parasitic charge in tissues 3 years Significance of the association between the histological grade defined by the Vienna classification of tumors and the species of Cryptosporidium and the parasitic charge in the tissues that will be determined by quantitative polymerase chain reaction (qPCR)
The rate of change in the expression or localization of certain markers known or suspected to be involved in the process of carcinogenesis. 3years Some markers known to be associated to cancer development will be explored such as: Beta-catenin, P53, APC (adenomatous polyposis coli), etc.
Rate of development of a neoplastic lesion in the human explants 3 years A three-dimensional culture model will be developed using colon samples from healthy tissues of several control patients. An experimental Cryptosporidium infection will be tested in order to determine the development of neoplastic lesions in these human explants.
Rate of occurrence of parasite development in the tumoral zone (yes/no) compared to the peri-tumoral zone. 3 years A biopsy or a surgical sample containing the tumoral and peri-tumoral areas will be collected only from the cases which will be then screened for Cryptosporidium using PCR
Significance of the association between the histological grade of the lesion and the Cryptosporidium species 3 years Significance of the association between the histological grade defined by the Vienna classification of tumors and the species of Cryptosporidium and the Cryptosporidium species.The main species of Cryptosporidium infecting humans are C. parvum and C. hominis, however, other species can also infect humans.
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 Because Cryptosporidium is an opportunistic agent that causes significant morbidity and mortality in immunocompromised patients, it is possible that individuals with malignancies, have a higher risk of developing infection with this parasite, especially when their immunosuppression is more severe. To rule out this possibility this association will be determined.
Trial Locations
- Locations (1)
Groupement des Hôpitaux de l'Institut Catholique de Lille
🇫🇷Lomme, Nord, France