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OpenTrials
Completed

NCT Number: NCT05648240

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disseminated Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Test

Other

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: Day 0

    ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay

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

    Time frame: Day 0

    ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay

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

    Time frame: Day 0

    ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay

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

    Time frame: Day 0

    ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay

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

    Time frame: Day 0

    ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay

  6. Concentration of Stromal cell-Derived Factor 1 (SDF-1) in the blood samples between groups

    Time frame: Day 0

    ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay

  7. Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Yes/no

  8. Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Yes/no

  9. Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Yes/no

  10. Reason for screening colonoscopy according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    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

  11. 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

  12. Quality of the preparation according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Boston classification: ranked from 0 to 3 for each colonic segment explored

  13. Caecal intubation rate according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    classed as complete colonoscopy after visualization of the caecal floor

  14. Per-surgical complications according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Post-polypectomy bleeding / Perforation / Incomplete colonoscopy / No complications

  15. Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Number

  16. 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

    Number

  17. Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    < 5mm / 5 - 10mm / > 10mm

  18. Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Rectum / Sigmoid / Left Colon / Transverse Colon / Right Colon / Caecum

  19. Morphology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Paris classification: 0-Is / 0-Ip / 0-IIa / 0-IIb / 0-IIc / 0-III

  20. Method of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Biopsy forceps / Cold loop / Diathermic loop / Mucosectomy / Unresected (Suspected Cancer, Unresectable in ambulatory)

  21. Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    Yes/no

  22. Histology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp

    Time frame: Day 0

    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.

  23. Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and membrane marker expression

    Time frame: Day 0

    Rectum / Sigmoid / Left Colon / Transverse Colon / Right Colon / Caecum

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: EARDIS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2022
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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