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

Colorectal Cancer Clinical Trial

— EARDIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648240
• Other study ID #: NIMAO/2022-1/JFB01
• Status: Recruiting
• Start date: February 23, 2023
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Jean-François BOURGAUX
• Phone: 04.66.68.81.85
• Email: jean.francois.bourgaux[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Intestinal Polyps
• Neoplasm Metastasis

Intervention

Other:
• Blood test
Venous blood samples taken at the moment of colonoscopy to test for biomarkers

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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