Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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