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

February 12, 2026 updated by: Hospices Civils de Lyon

Monitoring of Blood Clearance Kinetics of the Nucleosome and CTCF in Peri-operative Management of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peritoneal metastases colorectal cancer
  • 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
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
Experimental: Colorectal cancer
Histologically proven colorectal cancer with no known metastatic
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
Experimental: Non-oncological chronic inflammatory diseases
Surgery for inflammatory bowel disease (Crohn's, chronic ulcerative colitis) such as ileocaecal resection, colectomy, and bowel resection.
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
Experimental: Non-malignant diseases

Non-inflammatory and non-oncological diseases:

  • Parietal repairs.
  • Elective sigmoidectomy for diverticulosis
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
Experimental: Abdominal sepsis conditions
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinetic of inflammatory markers - Albumin
Time Frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Blood clearance kinetics of albumin
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.
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
Time Frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
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).
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).
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

June 20, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_0852

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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