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

NCT05648240 | Completed

• 1 other identifier: NIMAO/2022-1/JFB01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; Neoplasm Metastasis; Disseminated Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups

  Day 0

• Concentration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in the blood samples between groups.

  Day 0

• Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups.

  Day 0

• Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups

  Day 0

• Concentration of Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) in the blood samples between groups

  Day 0

Study Arms (2)

Patients with polyps

Other: Blood test

Patients without polyps

Other: Blood test

Interventions

Blood test OTHER

Venous blood samples taken at the moment of colonoscopy to test for biomarkers

Patients with polyps; Patients without polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood collected at time of colonoscopy

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jean-François BOURGAUX

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: February 23, 2023
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

FR (1)