Cryptosporidium Infection and Human Colorectal Cancer

NCT ID: NCT04332705

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colonic Neoplasms Cryptosporidiosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with colon cancer

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

Detection of Cryptosporidium infection

Intervention Type DIAGNOSTIC_TEST

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

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

Detection of Cryptosporidium infection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Detection of Cryptosporidium infection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Pasteur de Lille

OTHER

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bertrand Nunes, MD

Role: STUDY_DIRECTOR

GHICL

Gabriela Certad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Locations

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Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Nord, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie Paule Lebitasy, MD

Role: CONTACT

0033320225269

Berenice Marchant

Role: CONTACT

0033320225751

Facility Contacts

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Berenice Marchant

Role: primary

+33320225751

Other Identifiers

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RC-P0091

Identifier Type: -

Identifier Source: org_study_id

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