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NCT Number: NCT06929013

Blood Clearance Kinetics of the Nucleosome and CTCF in Peritoneal Metastasis Colorectal Cancer.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Kinetic of nucleosome and CCCTC-binding factor (CTCF)

    Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.

    Blood clearance kinetics of the nucleosome (H3K27me3, H3K36me3, H3.1 et H3K9me3) and CCCTC-binding factor (CTCF).

Secondary outcomes

  1. Kinetic of inflammatory markers - Albumin

    Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.

    Blood clearance kinetics of albumin

  2. Kinetic of inflammatory markers - C-reactive protein

    Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.

    Blood clearance kinetics of C-reactive protein

  3. Kinetic of inflammatory markers - Interleukin IL-6

    Time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.

    Blood clearance kinetics of Interleukin IL-6

  4. Correlation between inflammatory markers, nucleosome and CCCTC-binding factor (CTCF).

    Time frame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery

    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).

  5. Nucleosome and CCCTC-binding factor (CTCF) sensitivity and specificity

    Time frame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery

    To assess the sensitivity and specificity of the nucleosome and CCCTC-binding factor (CTCF) blood clearance kinetic for the colorectal cancer peritoneal metastatic condition

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent VILLENEUVE, PhD

CONTACT

[email protected]

+33478 864 536

Vahan KEPENEKIAN, MD, PhD

CONTACT

[email protected]

+33 478 862 371

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Monitoring of Blood Clearance Kinetics of the Nucleosome and CTCF in Peri-operative Management of Peritoneal Metastasis Colorectal Cancer.

Acronym: NUCLEAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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