NCT06929013

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2025Jun 2026

First Submitted

Initial submission to the registry

March 25, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

March 25, 2025

Last Update Submit

February 12, 2026

Conditions

Peritoneal CarcinomatosisPeritoneal Metastases From Colorectal Cancer

Keywords

BiomarkersPeritoneal carcinomatosisCTCFNucleosome

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (5)

  • Kinetic of inflammatory markers - Albumin

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

  • Kinetic of inflammatory markers - C-reactive protein

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

  • Kinetic of inflammatory markers - 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).

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

  • Nucleosome and CCCTC-binding factor (CTCF) sensitivity and specificity

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

Study Arms (5)

Peritoneal metastases colorectal cancer

EXPERIMENTAL

* 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

Colorectal cancer

EXPERIMENTAL

Histologically proven colorectal cancer with no known metastatic

Biological: Blood sampling

Non-oncological chronic inflammatory diseases

EXPERIMENTAL

Surgery for inflammatory bowel disease (Crohn's, chronic ulcerative colitis) such as ileocaecal resection, colectomy, and bowel resection.

Biological: Blood sampling

Non-malignant diseases

EXPERIMENTAL

Non-inflammatory and non-oncological diseases: * Parietal repairs. * Elective sigmoidectomy for diverticulosis

Biological: Blood sampling

Abdominal sepsis conditions

EXPERIMENTAL

* Peritonitis due to digestive perforation in non-oncological pathology. * Non-perforated appendicitis. * Cholecystitis.

Biological: Blood sampling

Interventions

Blood samplingBIOLOGICAL

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

Abdominal sepsis conditionsColorectal cancerNon-malignant diseasesNon-oncological chronic inflammatory diseasesPeritoneal metastases colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Common criteria:
  • Male/female over 18 years of age.
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Vahan KEPENEKIAN, MD, PhD

CONTACT

+33 478 862 371vahan.kepenekian@chu-lyon.fr

Laurent VILLENEUVE, PhD

CONTACT

+33478 864 536laurent.villeneuve@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Prospective multicohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 15, 2025

Study Start

May 6, 2025

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

FR(1)