Cryptosporidium Infection and Human Colorectal Cancer (Crypto-K)

Lille Catholic University

Status: Enrolling

Conditions: Cryptosporidiosis; Colonic Neoplasms

Treatments: Diagnostic Test: Detection of Cryptosporidium infection

Study type: Observational

Funder types: Other

Identifiers

NCT04332705

RC-P0091

Details and patient eligibility

About

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.

Enrollment: 324 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

324 participants in 2 patient groups

Patients with colon cancer

Description:

Patients with colon cancer of recent diagnosis will be recruited in consultation either in the surgical or gastroenterology departments

Treatment:

Diagnostic Test: Detection of Cryptosporidium infection

Patients without colon cancer

Description:

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

Treatment:

Diagnostic Test: Detection of Cryptosporidium infection