NCT05648240CompletedNot Applicable
Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients With Versus Without Intestinal Polyps
Centre Hospitalier Universitaire de Nīmes1 site in 1 country120 target enrollmentStarted: February 23, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with polyps
Intervention: Blood test (Other)
Patients without polyps
Intervention: Blood test (Other)
Outcomes
Primary Outcomes
Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps
Time Frame: Day 0
Number of disseminated circulating tumor cells found on the ANGLE Parsortix™ system
Secondary Outcomes
- Caecal intubation rate according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Total number of histologically validated resected colonic adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and membrane marker expression(Day 0)
- Concentration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in the blood samples between groups.(Day 0)
- Concentration of Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) in the blood samples between groups(Day 0)
- 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)
- Method of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups(Day 0)
- Concentration of Stromal cell-Derived Factor 1 (SDF-1) in the blood samples between groups(Day 0)
- Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Per-surgical complications according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups.(Day 0)
- Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Reason for screening colonoscopy according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Morphology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups(Day 0)
- Quality of the preparation according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Histology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma DetectionColorectal CancerNCT04146662University Hospitals Coventry and Warwickshire NHS Trust360
Completed
Not Applicable
Circulating Free DNA Analysis in Gastrointestinal Cancer, Genitourinary Cancer, Rare CancerGastric CancerNCT02067754Samsung Medical Center396
Withdrawn
Not Applicable
A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal CancerGastrointestinal MalignanciesNCT03749083Massachusetts General Hospital
Active, not recruiting
Not Applicable
Circulating Tumor Cells in Patients With Locally Advanced Rectal CancerLocally Advanced Rectal AdenocarcinomaMetastatic Rectal AdenocarcinomaRectosigmoid AdenocarcinomaRecurrent Rectal AdenocarcinomaRecurrent Rectosigmoid CarcinomaStage III Rectal Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8Stage IV Rectal Cancer AJCC v8Stage IVA Rectal Cancer AJCC v8Stage IVB Rectal Cancer AJCC v8Stage IVC Rectal Cancer AJCC v8NCT02874885M.D. Anderson Cancer Center341
Completed
Unknown
INTENT_Circulating tumor cells as biomarkers for recurrence risk in thermoablatioC22.0Liver cell carcinomaDRKS00016808Klinikum der Universität München, Campus Großhadern100