Clinical trial NCT05648240: Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients with Versus Without Intestinal Polyps
Official title: Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients with Versus Without Intestinal Polyps
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Neoplasm Metastasis
Disseminated Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for colonoscopy in the Hepato-Gastro-Enterology Department of the University Hospital of Nîmes. Patients with a family history of colorectal cancer and aged over 50 years, with a positive Fecal Immunological Test, with bleeding, with abdominal pain or with unexplained anemia are all likely to undergo colonoscopy

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.


Eligibility 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

Primary outcomes:
measure: Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps
timeFrame: Day 0
Secondary outcomes:
measure: Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups
timeFrame: Day 0
measure: Concentration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in the blood samples between groups.
timeFrame: Day 0
measure: Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups.
timeFrame: Day 0
measure: Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups
timeFrame: Day 0
measure: Concentration of Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) in the blood samples between groups
timeFrame: Day 0
measure: Concentration of Stromal cell-Derived Factor 1 (SDF-1) in the blood samples between groups
timeFrame: Day 0
measure: Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Reason for screening colonoscopy according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Screening colonoscopy operator (inter-operator tumor detection rate) according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Quality of the preparation according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Caecal intubation rate according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Per-surgical complications according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Total number of histologically validated resected colonic adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Morphology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Method of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Histology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
timeFrame: Day 0
measure: Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and membrane marker expression
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Jean-François BOURGAUX
role: PRINCIPAL_INVESTIGATOR
References: