Cryptosporidium Infection and Human Colorectal Cancer

Colonic Neoplasms Clinical Trial

— Crypto-K  

Official title:

Role of the Protozoa Cryptosporidium in the Development of Colorectal Cancer in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332705
• Other study ID #: RC-P0091
• Status: Recruiting
• Start date: June 30, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Lille Catholic University
• Contact: Marie Paule Lebitasy, MD
• Phone: 0033320225269
• Email: Lebitasy.Marie-Paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients undergoing pre-operative chemotherapy.
• Patients who have already had chemotherapy for less than one year or other immunosuppressive treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Cryptosporidiosis

Intervention

Diagnostic Test:
• Detection of Cryptosporidium infection
A biopsy or a surgical sample will be collected from every participant

Locations

Country	Name	City	State
France	Groupement des Hôpitaux de l'Institut Catholique de Lille	Lomme	Nord

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Institut Pasteur de Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Cryptosporidium	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	3 years
Secondary	Rate of occurrence of parasite development in the tumoral zone (yes/no) compared to the peri-tumoral zone.	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	3 years
Secondary	Significance of the association between the histological grade of the lesion and the Cryptosporidium species	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.	3 years
Secondary	Significance of the association between the histological grade of the lesion and the parasitic charge in tissues	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)	3 years
Secondary	The rate of change in the expression or localization of certain markers known or suspected to be involved in the process of carcinogenesis.	Some markers known to be associated to cancer development will be explored such as: Beta-catenin, P53, APC (adenomatous polyposis coli), etc.	3years
Secondary	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	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.	3 years
Secondary	Rate of development of a neoplastic lesion in the human explants	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.	3 years