Cryptosporidium Infection and Human Colorectal Cancer

NCT04332705 | Unknown

• 1 other identifier: RC-P0091
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms; Cryptosporidiosis

Keywords

Colon cancer; Cryptosporidiosis; Prevalence; Infection and cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of occurrence of parasite development in the tumoral zone (yes/no) compared to the peri-tumoral zone.

  3 years

• Significance of the association between the histological grade of the lesion and the Cryptosporidium species

  3 years

• Significance of the association between the histological grade of the lesion and the parasitic charge in tissues

  3 years

• The rate of change in the expression or localization of certain markers known or suspected to be involved in the process of carcinogenesis.

  3years

• 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

  3 years

Study Arms (2)

Patients with colon cancer

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

Diagnostic Test: Detection of Cryptosporidium infection

Patients without colon cancer

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

Diagnostic Test: Detection of Cryptosporidium infection

Interventions

Detection of Cryptosporidium infection DIAGNOSTIC_TEST

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

Patients with colon cancer; Patients without colon cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lille Catholic University: lead
• Institut Pasteur de Lille: collaborator

Study Sites (1)

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Nord, 59462, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Surgical specimens or biopsies

MeSH Terms

Conditions

Colonic Neoplasms; Cryptosporidiosis; Infections; Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Diseases, Parasitic; Parasitic Diseases; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Animal Diseases

Study Officials

• Bertrand Nunes, MD

  GHICL

  STUDY DIRECTOR

• Gabriela Certad, MD, PhD

  GHICL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule Lebitasy, MD

CONTACT

0033320225269; Lebitasy.Marie-Paule@ghicl.net

Berenice Marchant

CONTACT

0033320225751; marchant.berenice@ghicl.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 3, 2020
• Study Start: June 30, 2020
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)