An interventional study of Blood sampling in Peritoneal Carcinomatosis and Peritoneal Metastases From Colorectal Cancer, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
Colorectal cancer is highly prevalent in France, ranking second among women and third among men. Its primary metastatic sites include the liver, lungs, and peritoneum. For peritoneal metastases, when the disease is moderately extensive, cytoreductive surgery is recommended in an expert centre. Following this procedure, the surgeon uses the CC-Score (Completeness of Cytoreduction after Surgery Score) to assess the completeness of surgical resection by evaluating the largest remaining tumor residue. This subjective score is currently the main prognostic factor for oncological outcomes post-surgery. However, there is no objective score based on biological criteria to evaluate the radicality of resection, despite the hypothesis that the micrometastatic component of the disease could be biologically assessed using appropriate circulating markers.
New biomarkers are emerging and appear relevant for determining the presence of tumor residual disease. Notable among these are circulating tumor DNA, which can detect mutated DNA released by tumor cells into the patient's blood through high-throughput sequencing, and new markers related to epigenetic modifications in cancer cells. These markers target specific nucleosomes or the transcription factor CTCF and show promise in detecting residual disease.
To effectively use these markers for constructing a biological score to detect residual disease in peritoneal carcinomatosis, it is essential to understand their perioperative kinetics. This is crucial because cellular debris release is expected post-surgery, necessitating the determination of the most relevant time point for measurement. Additionally, these markers appear to be correlated with blood inflammation levels, requiring a description of this correlation to account for this potential confounding factor. Finally, the sensitivity and specificity of these markers must be determined by studying their perioperative kinetics in patient groups undergoing surgeries other than cytoreductions for peritoneal carcinomatosis.
361 studies on the registry are indexed under Peritoneal Neoplasms; 56 are open to participants now.
This study's planned enrollment of 58 is above the median of 45 across 288 interventional studies indexed under Peritoneal Neoplasms.
Browse Peritoneal Neoplasms studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Inclusion Criteria:
Common criteria:
Group 1:
Group 2:
Colorectal cancer
Group 3:
Non-oncological chronic inflammatory diseases
Group 4:
Non-oncological chronic inflammatory diseases : parietal repairs, elective sigmoidectomy for diverticulosis
Group 5:
Abdominal sepsis conditions: peritonitis due to digestive perforation in non-oncological pathology, non-perforated appendicitis, cholecystitis.
Non inclusion Criteria:
* Peritoneal metastases colorectal cancer histologically proven * Synchronous or metachronous peritoneal metastases. * Patients eligible for initial cytoreduction surgery. * Non mucinous tumor (mucinous cells contingent \<30%).
Biological: Blood sampling
Histologically proven colorectal cancer with no known metastatic
Biological: Blood sampling
Surgery for inflammatory bowel disease (Crohn's, chronic ulcerative colitis) such as ileocaecal resection, colectomy, and bowel resection.
Biological: Blood sampling
Non-inflammatory and non-oncological diseases: * Parietal repairs. * Elective sigmoidectomy for diverticulosis
Biological: Blood sampling
* Peritonitis due to digestive perforation in non-oncological pathology. * Non-perforated appendicitis. * Cholecystitis.
Biological: Blood sampling
Inclusion (baseline): 28 mL Incision (surgery): 18 mL End surgery: 18 mL H+12 after end surgery: 18 mL H+4 after end surgery: 18 mL H+48 after end surgery: 18 mL H+72 after end surgery: 18 mL D+7 after end surgery: 18 mL D+14 after surgery: 18 mL 4 to 6 weeks after surgery:28 mL
Kinetic of nucleosome and CCCTC-binding factor (CTCF)
Blood clearance kinetics of the nucleosome (H3K27me3, H3K36me3, H3.1 et H3K9me3) and CCCTC-binding factor (CTCF).
Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Kinetic of inflammatory markers - Albumin
Blood clearance kinetics of albumin
Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Kinetic of inflammatory markers - C-reactive protein
Blood clearance kinetics of C-reactive protein
Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Kinetic of inflammatory markers - Interleukin IL-6
Blood clearance kinetics of Interleukin IL-6
Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Correlation between inflammatory markers, nucleosome and CCCTC-binding factor (CTCF).
Correlation test between blood concentration of inflammatory markers (albumin, C-reactive protein, Interleukin IL-6), nucleosome nucleosome (H3K27me3, H3K36me3, H3.1 et H3K9me3) and CCCTC-binding factor (CTCF).
Time frame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery
Nucleosome and CCCTC-binding factor (CTCF) sensitivity and specificity
To assess the sensitivity and specificity of the nucleosome and CCCTC-binding factor (CTCF) blood clearance kinetic for the colorectal cancer peritoneal metastatic condition
Time frame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery
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