Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peritoneal metastases colorectal cancer | Experimental |
|
|
| Colorectal cancer | Experimental | Histologically proven colorectal cancer with no known metastatic |
|
| Non-oncological chronic inflammatory diseases | Experimental | Surgery for inflammatory bowel disease (Crohn's, chronic ulcerative colitis) such as ileocaecal resection, colectomy, and bowel resection. |
|
| Non-malignant diseases | Experimental | Non-inflammatory and non-oncological diseases:
|
|
| Abdominal sepsis conditions | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From the inclusion (baseline) to 4 to 6 weeks after surgical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetic of inflammatory markers - Albumin | Blood clearance kinetics of albumin | From the inclusion (baseline) to 4 to 6 weeks after surgical procedure. |
| Kinetic of inflammatory markers - C-reactive protein |
Not provided
Inclusion Criteria:
Common criteria:
Specific 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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vahan KEPENEKIAN, MD, PhD | Contact | +33 478 862 371 | vahan.kepenekian@chu-lyon.fr | |
| Laurent VILLENEUVE, PhD | Contact | +33478 864 536 | laurent.villeneuve@chu-lyon.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
Not provided
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Prospective multicohort study
Not provided
Not provided
Not provided
Not provided
|
Blood clearance kinetics of C-reactive protein
| 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 | 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). | 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 | Completed postoperative follow-up : at least 4 to 6 weeks after surgery |
| D004066 |
| Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |