Investigating the link between Cryptosporidium infection and colorectal cancer

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

This study is trying to see if there’s a connection between Cryptosporidium infection and colorectal cancer by looking at samples from patients with different digestive cancers and conditions.

Quick facts

• Study type: Observational
• Enrollment: 324 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lille Catholic University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Lomme, Nord)
• Trial ID: NCT04332705 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the potential association between Cryptosporidium infection and colorectal cancer by determining the prevalence of this protozoan among patients diagnosed with digestive cancers. It will involve collecting samples from patients with colonic adenocarcinoma and benign pathologies to identify the presence of Cryptosporidium species. The study will include both cases of colorectal cancer and controls with other digestive cancers or benign conditions, ensuring a comprehensive analysis of the infection's role in cancer development. The findings could provide insights into the relationship between opportunistic infections and gastrointestinal malignancies in humans.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with diagnosed colonic adenocarcinoma or benign digestive conditions requiring surgery.

Not a fit: Patients undergoing pre-operative chemotherapy or those with rectal cancer requiring neoadjuvant treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the role of Cryptosporidium in colorectal cancer, potentially leading to new prevention or treatment strategies.

How similar studies have performed: While some epidemiological studies have suggested a link between Cryptosporidium and colorectal cancer, this specific approach to investigate the prevalence in a targeted population is novel and has not been extensively tested.

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

Where this trial is running

Lomme, Nord

• Groupement des Hôpitaux de l'Institut Catholique de Lille — Lomme, Nord, France (RECRUITING)

Study contacts

• Principal investigator: Gabriela Certad, MD, PhD — GHICL
• Study coordinator: Marie Paule Lebitasy, MD

Conditions: Colonic Neoplasms, Cryptosporidiosis, Colon cancer, Prevalence, Infection and cancer