Colorectal CancerEARDISNCT05648240
Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients With Versus Without Intestinal Polyps
An observational study of Colorectal Cancer and Neoplasm Metastasis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The study authors hypothesize that in patients with intestinal polyps, tumor cells could disseminate and circulating factors could be secreted by the polyp. These two parameters could become biomarkers to refine the follow-up of patients and to establish targeted therapeutic strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Neoplasm Metastasis, Disseminated Cancer
- What is being tested?
- Blood test
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2023to 4 Feb 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for colonoscopy in the Hepato-Gastro-Enterology Department of the University Hospital of Nîmes. Patients with a family history of colorectal cancer and aged over 50 years, with a positive Fecal Immunological Test, with bleeding, with abdominal pain or with unexplained anemia are all likely to undergo colonoscopy
Who may be able to join
- Patient to be examined by colonoscopy
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject signals their opposition to participate in the study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant or breastfeeding
- History of proven cancerous disease
- Patient followed for a chronic inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
The study authors hypothesize that in patients with intestinal polyps, tumor cells could disseminate and circulating factors could be secreted by the polyp. These two parameters could become biomarkers to refine the follow-up of patients and to establish targeted therapeutic strategies.
- Conditions
- Colorectal Cancer, Neoplasm Metastasis, Disseminated Cancer
- Being tested
- Blood test
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Venous blood samples taken at the moment of colonoscopy to test for biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Patients with polyps | Not described Receives: Other: Blood test | |
| Patients without polyps | Not described Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps
Number of disseminated circulating tumor cells found on the ANGLE Parsortix™ system
Measured: Day 0
Secondary outcomes (23)
Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Measured: Day 0
Concentration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in the blood samples between groups.
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Measured: Day 0
Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups.
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Measured: Day 0
Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Measured: Day 0
Concentration of Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) in the blood samples between groups
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Measured: Day 0
Concentration of Stromal cell-Derived Factor 1 (SDF-1) in the blood samples between groups
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Measured: Day 0
Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Yes/no
Measured: Day 0
Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Yes/no
Measured: Day 0
Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp
Yes/no
Measured: Day 0
Reason for screening colonoscopy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Fecal immunochemical test positive / Personal history of colonic adenoma / Family history of colonic adenoma / Personal history of colorectal cancer / Family history of colorectal cancer / Rectal symptoms
Measured: Day 0
Screening colonoscopy operator (inter-operator tumor detection rate) according to presence of circulating tumor cells, cytokine presence and presence of polyp
Measured: Day 0
Quality of the preparation according to presence of circulating tumor cells, cytokine presence and presence of polyp
Boston classification: ranked from 0 to 3 for each colonic segment explored
Measured: Day 0
Caecal intubation rate according to presence of circulating tumor cells, cytokine presence and presence of polyp
classed as complete colonoscopy after visualization of the caecal floor
Measured: Day 0
Per-surgical complications according to presence of circulating tumor cells, cytokine presence and presence of polyp
Post-polypectomy bleeding / Perforation / Incomplete colonoscopy / No complications
Measured: Day 0
Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp
Number
Measured: Day 0
Total number of histologically validated resected colonic adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Number
Measured: Day 0
Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
< 5mm / 5 - 10mm / > 10mm
Measured: Day 0
Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Rectum / Sigmoid / Left Colon / Transverse Colon / Right Colon / Caecum
Measured: Day 0
Morphology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Paris classification: 0-Is / 0-Ip / 0-IIa / 0-IIb / 0-IIc / 0-III
Measured: Day 0
Method of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Biopsy forceps / Cold loop / Diathermic loop / Mucosectomy / Unresected (Suspected Cancer, Unresectable in ambulatory)
Measured: Day 0
Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp
Yes/no
Measured: Day 0
Histology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Vienna classification: Nonspecific (Food Residue, Normal Mucosa or Colonic Fold) / Adenoma in Low Grade Dysplasia / Adenoma in High Grade Dysplasia / Cancer - Transformed Adenoma / Scalloped Adenoma / Hyperplastic Polyp.
Measured: Day 0
Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and membrane marker expression
Rectum / Sigmoid / Left Colon / Transverse Colon / Right Colon / Caecum
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start23 Feb 2023
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François BOURGAUX, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648240
- Sponsor's protocol ID
- NIMAO/2022-1/JFB01
- Acronym
- EARDIS
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients With Versus Without Intestinal Polyps
- ClinicalTrials.gov ID
- NCT05648240
- Acronym / sponsor ID
- EARDIS / NIMAO/2022-1/JFB01
- Conditions
- Colorectal Cancer, Neoplasm Metastasis, Disseminated Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 13 Dec 2022 (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.
The study authors hypothesize that in patients with intestinal polyps, tumor cells could disseminate and circulating factors could be secreted by the polyp. These two parameters could become biomarkers to refine the follow-up of patients and to establish targeted therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with polyps | – | Other: Blood test |
| Patients without polyps | – | Other: Blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for colonoscopy in the Hepato-Gastro-Enterology Department of the University Hospital of Nîmes. Patients with a family history of colorectal cancer and aged over 50 years, with a positive Fecal Immunological Test, with bleeding, with abdominal pain or with unexplained anemia are all likely to undergo colonoscopy
Key inclusion criteria (2 listed)
- Patient to be examined by colonoscopy
- The patient must be a member or beneficiary of a health insurance plan
Key exclusion criteria (7 listed)
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject signals their opposition to participate in the study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant or breastfeeding
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 |
|---|---|---|
| Blood testVenous blood samples taken at the moment of colonoscopy to test for biomarkers | Other | Patients with polyps, Patients without polyps |
Primary outcome
Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps
Time frame: Day 0
Number of disseminated circulating tumor cells found on the ANGLE Parsortix™ system
23 secondary outcomes
Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups
Time frame: Day 0
Concentration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in the blood samples between groups.
Time frame: Day 0
Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups.
Time frame: Day 0
Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups
Time frame: Day 0
Concentration of Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) in the blood samples between groups
Time frame: Day 0
Concentration of Stromal cell-Derived Factor 1 (SDF-1) in the blood samples between groups
Time frame: Day 0
Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Reason for screening colonoscopy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Screening colonoscopy operator (inter-operator tumor detection rate) according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Quality of the preparation according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Caecal intubation rate according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Per-surgical complications according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Total number of histologically validated resected colonic adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Morphology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Method of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Histology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time frame: Day 0
Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and membrane marker expression
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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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.
Jean-François BOURGAUX principal investigator
CHU de Nimes
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 Colorectal Cancer and Neoplasm Metastasis, run by Centre Hospitalier Universitaire de Nīmes 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 10 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps (time frame: Day 0). 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 10 Feb 2026.