Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06929013

Monitoring Blood Clearance of Nucleosome and CTCF During Surgery for Peritoneal Metastases from Colorectal Cancer

Led by Hospices Civils de Lyon · Updated on 2026-02-13

58

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Colorectal cancer is a common disease in France, often spreading to the liver, lungs, and peritoneum. For patients with moderate peritoneal metastases, cytoreductive surgery is usually recommended at specialized centers. After surgery, doctors use a score called the CC-Score to evaluate how completely the tumor was removed, but this is a subjective measure. The study aims to explore new biological markers, such as circulating tumor DNA and markers related to epigenetic changes, to develop an objective score for detecting leftover disease after surgery. Participants will undergo blood sampling at multiple time points, from before surgery through 4 to 6 weeks after the procedure, to monitor the levels and clearance of nucleosomes and the transcription factor CTCF. The study includes different patient groups, including those with peritoneal metastases from colorectal cancer, colorectal cancer without metastases, non-oncological chronic inflammatory diseases, and non-malignant abdominal conditions. The blood samples will help understand how these markers change around surgery and how they relate to inflammation and residual disease. During the study, participants will have blood taken at baseline, during surgery, and multiple times post-surgery up to 6 weeks later. Researchers will measure the kinetics of nucleosomes, CTCF, and inflammatory markers like albumin, C-reactive protein, and interleukin IL-6. They will analyze how these markers correlate and evaluate their accuracy in detecting residual disease. The total study period for each participant covers up to 4 to 6 weeks after surgery, with close monitoring of biological markers and inflammation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Weight of at least 55 kg at inclusion
  • Signed informed consent form
  • For Group 1: Histologically confirmed peritoneal metastases from colorectal cancer
  • Synchronous or metachronous peritoneal metastases
  • Eligible for initial cytoreductive surgery
  • Non-mucinous tumor with mucinous cells less than 30%
  • For Group 2: Diagnosed colorectal cancer
  • For Group 3: Non-oncological chronic inflammatory diseases
  • For Group 4: Non-oncological chronic inflammatory diseases such as parietal repairs and elective sigmoidectomy for diverticulosis
  • For Group 5: Abdominal sepsis conditions including peritonitis from digestive perforation, non-perforated appendicitis, and cholecystitis
Not Eligible

You will not qualify if you...

  • Active cancer other than colorectal cancer
  • Progressive autoimmune disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and up to 72 hours after surgery

Participants undergo cytoreductive surgery during which blood samples are taken at multiple time points including at incision, end of surgery, and several hours after surgery to monitor biological markers.

Multiple blood sampling time points on surgery day and within 72 hours post-surgery

Post-operative Follow-up

Duration - Up to 4 to 6 weeks after surgery

Participants have blood samples collected at 7 days, 14 days, and 4 to 6 weeks after surgery to monitor the kinetics of nucleosome, CCCTC-binding factor (CTCF), and inflammatory markers.

3 visits for blood sampling at 7 days, 14 days, and 4 to 6 weeks post-surgery

Trial Site Locations

Total: 1 location

1

Hôpital Lyon Sud

Pierre-Bénite, France, 69310

Actively Recruiting

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Research Team

V

Vahan KEPENEKIAN, MD, PhD

L

Laurent VILLENEUVE, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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