Colonic NeoplasmsCrypto-KNCT04332705
Cryptosporidium Infection and Human Colorectal Cancer
An observational study of Colonic Neoplasms and Cryptosporidiosis, run by Lille Catholic University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Cryptosporidiosis
- What is being tested?
- Detection of Cryptosporidium infection
- How many people
- 324,117 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to 8 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Patients undergoing pre-operative chemotherapy.
- Patients who have already had chemotherapy for less than one year or other immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
France1 site
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lomme, Nord, 59462
About this study
Official title: Role of the Protozoa Cryptosporidium in the Development of Colorectal Cancer in Humans
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
- Being tested
- Detection of Cryptosporidium infection
- Keywords
- Colon cancer, Cryptosporidiosis, Prevalence, Infection and cancer
- Medical subject headings
- Colonic Neoplasms, Cryptosporidiosis, Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Cryptosporidium infectionDiagnostic test
A biopsy or a surgical sample will be collected from every participant
| Study group | Role | What they receive |
|---|---|---|
| Patients with colon cancer | Patients with colon cancer of recent diagnosis will be recruited in consultation either in the surgical or gastroenterology departments Receives: 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 Receives: Diagnostic Test: Detection of Cryptosporidium infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (6)
Rate of occurrence of parasite development in the tumoral zone (yes/no) compared to the peri-tumoral zone.
A biopsy or a surgical sample containing the tumoral and peri-tumoral areas will be collected only from the cases which will be then screened for Cryptosporidium using PCR
Measured: 3 years
Significance of the association between the histological grade of the lesion and the Cryptosporidium species
Significance of the association between the histological grade defined by the Vienna classification of tumors and the species of Cryptosporidium and the Cryptosporidium species.The main species of Cryptosporidium infecting humans are C. parvum and C. hominis, however, other species can also infect humans.
Measured: 3 years
Significance of the association between the histological grade of the lesion and the parasitic charge in tissues
Significance of the association between the histological grade defined by the Vienna classification of tumors and the species of Cryptosporidium and the parasitic charge in the tissues that will be determined by quantitative polymerase chain reaction (qPCR)
Measured: 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.
Some markers known to be associated to cancer development will be explored such as: Beta-catenin, P53, APC (adenomatous polyposis coli), etc.
Measured: 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
Because Cryptosporidium is an opportunistic agent that causes significant morbidity and mortality in immunocompromised patients, it is possible that individuals with malignancies, have a higher risk of developing infection with this parasite, especially when their immunosuppression is more severe. To rule out this possibility this association will be determined.
Measured: 3 years
Rate of development of a neoplastic lesion in the human explants
A three-dimensional culture model will be developed using colon samples from healthy tissues of several control patients. An experimental Cryptosporidium infection will be tested in order to determine the development of neoplastic lesions in these human explants.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start30 Jun 2020
- Primary completion6 Jun 2025
- Study completion8 Jun 2025
Why it stopped: No other patients could be included within the time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 324,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Lille
- Responsible party
- Sponsor
- Investigators
- Bertrand Nunes, MD, Study director, GHICLGabriela Certad, MD, PhD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332705
- Sponsor's protocol ID
- RC-P0091
- Acronym
- Crypto-K
- Status last verified
- Nov 2026
- First submitted
- 31 Mar 2020
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Protozoa Cryptosporidium in the Development of Colorectal Cancer in Humans
- ClinicalTrials.gov ID
- NCT04332705
- Acronym / sponsor ID
- Crypto-K / RC-P0091
- Conditions
- Colonic Neoplasms, Cryptosporidiosis
- Keywords
- Colon cancer, Cryptosporidiosis, Prevalence, Infection and cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No other patients could be included within the time frame.
- Enrolment
- 324,117 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Institut Pasteur de Lille
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 8 Jun 2025 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with colon cancer | – | Diagnostic Test: Detection of Cryptosporidium infectionPatients with colon cancer of recent diagnosis will be recruited in consultation either in the surgical or gastroenterology departments |
| Patients without colon cancer | – | Diagnostic Test: Detection of Cryptosporidium infectionPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (2 listed)
- Patients undergoing pre-operative chemotherapy.
- Patients who have already had chemotherapy for less than one year or other immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of Cryptosporidium infectionA biopsy or a surgical sample will be collected from every participant | Diagnostic test | Patients with colon cancer, Patients without colon cancer |
Primary outcome
Prevalence of Cryptosporidium
Time frame: 3 years
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
6 secondary outcomes
Rate of occurrence of parasite development in the tumoral zone (yes/no) compared to the peri-tumoral zone.
Time frame: 3 years
Significance of the association between the histological grade of the lesion and the Cryptosporidium species
Time frame: 3 years
Significance of the association between the histological grade of the lesion and the parasitic charge in tissues
Time frame: 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.
Time frame: 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
Time frame: 3 years
Rate of development of a neoplastic lesion in the human explants
Time frame: 3 years
Results and safety
The study was stopped early (reason given: No other patients could be included within the time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Related trials for Colonic Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Nunes, MD study director
GHICL
Gabriela Certad, MD, PhD principal investigator
GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Neoplasms and Cryptosporidiosis, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No other patients could be included within the time frame.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Cryptosporidium (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.