EARDIS: Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients With Versus Without Intestinal Polyps
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with polyps
|
Other: Blood test
Venous blood samples taken at the moment of colonoscopy to test for biomarkers
|
| Patients without polyps
|
Other: Blood test
Venous blood samples taken at the moment of colonoscopy to test for biomarkers
|
Outcome Measures
Primary Outcome Measures
- 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
- Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups [Day 0]
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
- 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 Chemokine ligand 2 (CCL-2) in the blood samples between groups. [Day 0]
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
- 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 Tissue Inhibitor of Metalloproteinase 1 (TIMP-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-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp [Day 0]
Yes/no
- 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
- 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
- Screening colonoscopy operator (inter-operator tumor detection rate) according to presence of circulating tumor cells, cytokine presence and presence of polyp [Day 0]
- 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
- 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
- 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
- Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp [Day 0]
Number
- 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
- 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
- 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)
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nîmes | Nîmes | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Jean-François BOURGAUX, CHU de Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIMAO/2022-1/JFB01