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Cryptosporidium Infection and Human Colorectal Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04332705
Acronym
Crypto-K
Enrollment
324
Registered
2020-04-03
Start date
2020-06-30
Completion date
2024-12-30
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms, Cryptosporidiosis

Keywords

Colon cancer, Cryptosporidiosis, Prevalence, Infection and cancer

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.

Interventions

DIAGNOSTIC_TESTDetection of Cryptosporidium infection

A biopsy or a surgical sample will be collected from every participant

Sponsors

Institut Pasteur de Lille
CollaboratorOTHER
Lille Catholic University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Cryptosporidium3 yearsA 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

MeasureTime frameDescription
Significance of the association between the histological grade of the lesion and the Cryptosporidium species3 yearsSignificance 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.
Significance of the association between the histological grade of the lesion and the parasitic charge in tissues3 yearsSignificance 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)
Rate of occurrence of parasite development in the tumoral zone (yes/no) compared to the peri-tumoral zone.3 yearsA 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
The association between the rate of lymphocytes (CD3, CD4, CD8, CD19 and CD4/CD8 ratio) and the presence of parasites in biopsies or surgical specimens3 yearsBecause 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.
Rate of development of a neoplastic lesion in the human explants3 yearsA 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.
The rate of change in the expression or localization of certain markers known or suspected to be involved in the process of carcinogenesis.3yearsSome markers known to be associated to cancer development will be explored such as: Beta-catenin, P53, APC (adenomatous polyposis coli), etc.

Countries

France

Contacts

Primary ContactMarie Paule Lebitasy, MD
Lebitasy.Marie-Paule@ghicl.net0033320225269
Backup ContactBerenice Marchant
marchant.berenice@ghicl.net0033320225751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026