Clinical trial NCT06929013: Blood Clearance Kinetics of the Nucleosome and CTCF in Peritoneal Metastasis Colorectal Cancer.
Official title: Monitoring of Blood Clearance Kinetics of the Nucleosome and CTCF in Peri-operative Management of Peritoneal Metastasis Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peritoneal Carcinomatosis
Peritoneal Metastases From Colorectal Cancer
Keywords: Biomarkers
Peritoneal carcinomatosis
CTCF
Nucleosome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective multicohort study
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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.

Primary outcomes:
measure: Kinetic of nucleosome and CCCTC-binding factor (CTCF)
timeFrame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Secondary outcomes:
measure: Kinetic of inflammatory markers - Albumin
timeFrame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
measure: Kinetic of inflammatory markers - C-reactive protein
timeFrame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
measure: Kinetic of inflammatory markers - Interleukin IL-6
timeFrame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
measure: Correlation between inflammatory markers, nucleosome and CCCTC-binding factor (CTCF).
timeFrame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery
measure: Nucleosome and CCCTC-binding factor (CTCF) sensitivity and specificity
timeFrame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery
Other outcomes:
Locations:
city: Pierre-benite
country: France
facility: Hôpital Lyon Sud
Study officials:
References: