Clinical trial NCT04332705: Cryptosporidium Infection and Human Colorectal Cancer
Official title: Role of the Protozoa Cryptosporidium in the Development of Colorectal Cancer in Humans
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colonic Neoplasms
Cryptosporidiosis
Keywords: Colon cancer
Cryptosporidiosis
Prevalence
Infection and cancer
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Lille
First posted: 2020-04-03
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cases will be the patients with colon cancer of recent diagnosis recruited in consultation either in the surgical or gastroenterology departments. The controls will be the patients without colon cancer but with other gastrointestinal pathology needing a biopsy or a surgical procedure and recruited either in the surgical or gastroenterology departments

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Cryptosporidium
timeFrame: 3 years
Secondary outcomes:
measure: Rate of occurrence of parasite development in the tumoral zone (yes/no) compared to the peri-tumoral zone.
timeFrame: 3 years
measure: Significance of the association between the histological grade of the lesion and the Cryptosporidium species
timeFrame: 3 years
measure: Significance of the association between the histological grade of the lesion and the parasitic charge in tissues
timeFrame: 3 years
measure: The rate of change in the expression or localization of certain markers known or suspected to be involved in the process of carcinogenesis.
timeFrame: 3years
measure: 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
timeFrame: 3 years
measure: Rate of development of a neoplastic lesion in the human explants
timeFrame: 3 years
Other outcomes:
Locations:
city: Lomme
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
state: Nord
Study officials:
affiliation: GHICL
name: Bertrand Nunes, MD
role: STUDY_DIRECTOR
affiliation: GHICL
name: Gabriela Certad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: