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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04332705
Other study ID # RC-P0091
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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