Blood Clearance Kinetics of the Nucleosome and CTCF in Peritoneal Metastasis Colorectal Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling.
- Who it may be relevant to
- Registry conditions: Peritoneal Carcinomatosis, Peritoneal Metastases From Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Monitoring of Blood Clearance Kinetics of the Nucleosome and CTCF in Peri-operative Management of Peritoneal Metastasis Colorectal Cancer.
Overview
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.
Interventions
- 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
Primary outcome measures
- Kinetic of nucleosome and CCCTC-binding factor (CTCF) [Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.]
Secondary outcome measures (5)
- Kinetic of inflammatory markers - Albumin [Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.]
- Kinetic of inflammatory markers - C-reactive protein [Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.]
- Kinetic of inflammatory markers - 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). [Time frame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery]
- Nucleosome and CCCTC-binding factor (CTCF) sensitivity and specificity [Time frame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery]
Eligibility criteria
Inclusion criteria
- Common criteria:
- Male/female over 18 years of age.
- Weight ≥ 55 kg at inclusion.
- Signature of a free and informed consent form.
- Specific criteria:
Group 1:
- Peritoneal metastases colorectal cancer histologically proven
- Synchronous or metachronous peritoneal metastases.
- Patients eligible for initial cytoreduction surgery.
- Non mucinous tumor (mucinous cells contingent <30%).
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:
- Patient with an active cancer (excluding colorectal cancer).
- Person with a progressive autoimmune disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Hôpital Lyon Sud — Pierre-Bénite
Identifiers
NCT: NCT06929013 · 69HCL24_0852