Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients With Versus Without Intestinal Polyps (EARDIS)

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 Overview

• Status: Completed
• Conditions: Neoplasm Metastasis; Colorectal Cancer; Disseminated Cancer
• Intervention / Treatment: Other: Blood test

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• Patient to be examined by colonoscopy
• The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with polyps	Other: Blood test; Venous blood samples taken at the moment of colonoscopy to test for biomarkers
Patients without polyps	Other: Blood test; Venous blood samples taken at the moment of colonoscopy to test for biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups	ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay	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	Day 0
Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups.	ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay	Day 0
Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups	ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay	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	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	Day 0
Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp	Yes/no	Day 0
Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp	Yes/no	Day 0
Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp	Yes/no	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	Day 0
Screening colonoscopy operator (inter-operator tumor detection rate) according to presence of circulating tumor cells, cytokine presence and presence of polyp		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	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	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	Day 0
Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp	Number	Day 0
Total number of histologically validated resected colonic adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp	Number	Day 0
Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp	< 5mm / 5 - 10mm / > 10mm	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	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	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)	Day 0
Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp	Yes/no	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.	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	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean-François BOURGAUX, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): February 4, 2026
• Study Completion (Actual): February 4, 2026

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Neoplasm Metastasis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: NIMAO/2022-1/JFB01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No