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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05648240
Other study ID # NIMAO/2022-1/JFB01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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