Peritoneal CarcinomatosisNUCLEARNCT06929013
Blood Clearance Kinetics of the Nucleosome and CTCF in Peritoneal Metastasis Colorectal Cancer.
A study testing Blood sampling in people with Peritoneal Carcinomatosis and Peritoneal Metastases From Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis, Peritoneal Metastases From Colorectal Cancer
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 21Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite, 69310
Vahan KEPENEKIAN, MD, PhD, +33478862371, vahan.kepenekian@chu-lyon.fr
Laurent VILLENEUVE, PhD, +33478 864 536, laurent.villeneuve@chu-lyon.fr
About this study
Official title: 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.
- Being tested
- Blood sampling
- Keywords
- Biomarkers, Peritoneal carcinomatosis, CTCF, Nucleosome
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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%). Receives: Biological: Blood sampling |
| Colorectal cancer | Experimental | Histologically proven colorectal cancer with no known metastatic Receives: 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. Receives: Biological: Blood sampling |
| Non-malignant diseases | Experimental | Non-inflammatory and non-oncological diseases:
* Parietal repairs.
* Elective sigmoidectomy for diverticulosis Receives: Biological: Blood sampling |
| Abdominal sepsis conditions | Experimental | * Peritonitis due to digestive perforation in non-oncological pathology.
* Non-perforated appendicitis.
* Cholecystitis. Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Secondary outcomes (5)
Kinetic of inflammatory markers - Albumin
Blood clearance kinetics of albumin
Measured: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Kinetic of inflammatory markers - C-reactive protein
Blood clearance kinetics of C-reactive protein
Measured: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Kinetic of inflammatory markers - Interleukin IL-6
Blood clearance kinetics of Interleukin IL-6
Measured: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
Correlation between inflammatory markers, nucleosome and CCCTC-binding factor (CTCF).
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).
Measured: Completed postoperative follow-up : at least 4 to 6 weeks after surgery
Nucleosome and CCCTC-binding factor (CTCF) sensitivity and specificity
To assess the sensitivity and specificity of the nucleosome and CCCTC-binding factor (CTCF) blood clearance kinetic for the colorectal cancer peritoneal metastatic condition
Measured: Completed postoperative follow-up : at least 4 to 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start6 May 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective multicohort study
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929013
- Sponsor's protocol ID
- 69HCL24_0852
- Acronym
- NUCLEAR
- Status last verified
- Feb 2026
- First submitted
- 25 Mar 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Blood Clearance Kinetics of the Nucleosome and CTCF in Peri-operative Management of Peritoneal Metastasis Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT06929013
- Acronym / sponsor ID
- NUCLEAR / 69HCL24_0852
- Keywords
- Biomarkers, Peritoneal carcinomatosis, CTCF, Nucleosome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Prospective multicohort study
| Arm | Type | Receives |
|---|---|---|
| Peritoneal metastases colorectal cancer | Experimental | Biological: Blood sampling* Peritoneal metastases colorectal cancer histologically proven * Synchronous or metachronous peritoneal metastases. * Patients eligible for initial cytoreduction surgery. * Non mucinous tumor (mucinous cells contingent <30%). |
| Colorectal cancer | Experimental | Biological: Blood samplingHistologically proven colorectal cancer with no known metastatic |
| Non-oncological chronic inflammatory diseases | Experimental | Biological: Blood samplingSurgery for inflammatory bowel disease (Crohn's, chronic ulcerative colitis) such as ileocaecal resection, colectomy, and bowel resection. |
| Non-malignant diseases | Experimental | Biological: Blood samplingNon-inflammatory and non-oncological diseases: * Parietal repairs. * Elective sigmoidectomy for diverticulosis |
| Abdominal sepsis conditions | Experimental | Biological: Blood sampling* Peritonitis due to digestive perforation in non-oncological pathology. * Non-perforated appendicitis. * Cholecystitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Common criteria:
- Specific criteria:
- Peritoneal metastases colorectal cancer histologically proven
- Synchronous or metachronous peritoneal metastases.
- Patients eligible for initial cytoreduction surgery.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingInclusion (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 | Biological | Abdominal sepsis conditions, Colorectal cancer, Non-malignant diseases, Non-oncological chronic inflammatory diseases, Peritoneal metastases colorectal cancer |
Primary outcome
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).
5 secondary outcomes
Kinetic of inflammatory markers - Albumin
Time frame: 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.
Kinetic of inflammatory markers - Interleukin IL-6
Time frame: 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
Nucleosome and CCCTC-binding factor (CTCF) sensitivity and specificity
Time frame: Completed postoperative follow-up : at least 4 to 6 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Peritoneal Carcinomatosis and Peritoneal Metastases From Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vahan KEPENEKIAN, MD, PhD (+33 478 862 371, vahan.kepenekian@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetic of nucleosome and CCCTC-binding factor (CTCF) (time frame: From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.