Blood clearance of nucleosomes and CTCF after surgery for colorectal cancer with peritoneal spread
Monitoring of Blood Clearance Kinetics of the Nucleosome and CTCF in Peri-operative Management of Peritoneal Metastasis Colorectal Cancer.
This test will see if blood levels of nucleosomes and CTCF can indicate whether adults with colorectal cancer that has spread to the peritoneum have had all visible tumor removed by cytoreductive surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT06929013 on ClinicalTrials.gov |
What this trial studies
Researchers will collect blood samples around the time of cytoreductive surgery to measure circulating nucleosomes and CTCF and compare their clearance kinetics to the surgeon's CC-Score. Multiple comparison groups include patients with colorectal peritoneal metastases eligible for surgery and several non-oncological inflammatory and septic abdominal conditions. The aim is to correlate biomarker kinetics with residual tumor burden and surgical completeness using objective biological measures. The study is conducted at Hôpital Lyon Sud within the Hospices Civils de Lyon.
Who should consider this trial
Good fit: Adults (≥18 years) weighing at least 55 kg with histologically proven colorectal peritoneal metastases, non-mucinous tumors (<30% mucinous) and who are eligible for initial cytoreductive surgery are the ideal candidates.
Not a fit: Patients with active non-colorectal cancers, progressive autoimmune disease, or those not undergoing cytoreductive surgery are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide an objective blood-based marker to detect residual disease after cytoreductive surgery and help guide additional treatment and follow-up.
How similar studies have performed: Previous work has shown promise for circulating nucleosomes and other cell-free biomarkers in detecting residual cancer, but applying clearance kinetics of nucleosomes and CTCF specifically to peritoneal metastases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pierre-Bénite
- Hôpital Lyon Sud — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Vahan KEPENEKIAN, MD, PhD
- Email: vahan.kepenekian@chu-lyon.fr
- Phone: +33 478 862 371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.