Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients with Versus Without Intestinal Polyps
- Conditions
- Neoplasm MetastasisDisseminated CancerColorectal Cancer
- Interventions
- Other: Blood test
- Registration Number
- NCT05648240
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Patient to be examined by colonoscopy
- The patient must be a member or beneficiary of a health insurance plan
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients without polyps Blood test - Patients with polyps Blood test -
- Primary Outcome Measures
Name Time Method Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps Day 0 Number of disseminated circulating tumor cells found on the ANGLE Parsortix™ system
- Secondary Outcome Measures
Name Time Method Concentration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in the blood samples between groups. Day 0 ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Concentration of Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) in the blood samples between groups Day 0 ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Screening colonoscopy operator (inter-operator tumor detection rate) according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Number
Method of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Biopsy forceps / Cold loop / Diathermic loop / Mucosectomy / Unresected (Suspected Cancer, Unresectable in ambulatory)
Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups Day 0 ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Concentration of Stromal cell-Derived Factor 1 (SDF-1) in the blood samples between groups Day 0 ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Yes/no
Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Yes/no
Per-surgical complications according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Post-polypectomy bleeding / Perforation / Incomplete colonoscopy / No complications
Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups. Day 0 ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Yes/no
Reason for screening colonoscopy according to presence of circulating tumor cells, cytokine presence and presence of polyp 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
Morphology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Paris classification: 0-Is / 0-Ip / 0-IIa / 0-IIb / 0-IIc / 0-III
Caecal intubation rate according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 classed as complete colonoscopy after visualization of the caecal floor
Total number of histologically validated resected colonic adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Number
Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 \< 5mm / 5 - 10mm / \> 10mm
Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Rectum / Sigmoid / Left Colon / Transverse Colon / Right Colon / Caecum
Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and membrane marker expression Day 0 Rectum / Sigmoid / Left Colon / Transverse Colon / Right Colon / Caecum
Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups Day 0 ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Quality of the preparation according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Boston classification: ranked from 0 to 3 for each colonic segment explored
Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp Day 0 Yes/no
Histology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp 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.
Trial Locations
- Locations (1)
CHU de Nîmes
🇫🇷Nîmes, France