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L'essai clinique NCT06929013 (NUCLEAR) pour Carcinomatose péritonéale, Métastases péritonéales du cancer colorectal est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Blood Clearance Kinetics of the Nucleosome and CTCF in Peritoneal Metastasis Colorectal Cancer. (NUCLEAR)
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L'étude clinique NCT06929013 (NUCLEAR) est un essai interventionnel pour Carcinomatose péritonéale, Métastases péritonéales du cancer colorectal. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 15 avril 2025, avec un objectif de 52 participants. Dirigé par Hospices Civils de Lyon, l'essai devrait être terminé d'ici le 30 mai 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 15 avril 2025.
Résumé succinct
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.
Titre officiel
Monitoring of Blood Clearance Kinetics of the Nucleosome and CTCF in Peri-operative Management of Peritoneal Metastasis Colorectal Cancer.
Conditions
Carcinomatose péritonéaleMétastases péritonéales du cancer colorectalAutres identifiants de l'essai
- NUCLEAR
- 69HCL24_0852
Numéro NCT
Date de début (réel)
2025-04-15
Dernière mise à jour publiée
2025-04-15
Date de fin (estimée)
2026-05-30
Inscription (estimée)
52
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Biomarkers
Peritoneal carcinomatosis
CTCF
Nucleosome
Peritoneal carcinomatosis
CTCF
Nucleosome
Objectif principal
Recherche fondamentale
Plan d'attribution
Non aléatoire
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPeritoneal metastases colorectal cancer * Peritoneal metastases colorectal cancer histologically proven
* Synchronous or metachronous peritoneal metastases.
* Patients eligible for initial cytoreduction surgery.
* Non mucinous tumor (mucinous cells contingent \<30%). | Prélèvement sanguin 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 |
ExpérimentalColorectal cancer Histologically proven colorectal cancer with no known metastatic | Prélèvement sanguin 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 |
ExpérimentalNon-oncological chronic inflammatory diseases Surgery for inflammatory bowel disease (Crohn's, chronic ulcerative colitis) such as ileocaecal resection, colectomy, and bowel resection. | Prélèvement sanguin 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 |
ExpérimentalNon-malignant diseases Non-inflammatory and non-oncological diseases:
* Parietal repairs.
* Elective sigmoidectomy for diverticulosis | Prélèvement sanguin 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 |
ExpérimentalAbdominal sepsis conditions * Peritonitis due to digestive perforation in non-oncological pathology.
* Non-perforated appendicitis.
* Cholecystitis. | Prélèvement sanguin 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 |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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. |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Kinetic of inflammatory markers - Albumin | Blood clearance kinetics of albumin | 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 | 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 | 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). | 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 | Completed postoperative follow-up : at least 4 to 6 weeks after surgery |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
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.
Hospices Civils de LyonContact central de l'essai
Contact: Vahan KEPENEKIAN, MD, PhD, +33 478 862 371, [email protected]
Contact: Laurent VILLENEUVE, PhD, +33478 864 536, [email protected]
1 Centres de l'essai dans 1 pays
Hôpital Lyon Sud, Pierre-Bénite, 69310, France
Vahan KEPENEKIAN, MD, PhD, Contact, +33478862371, [email protected]
Laurent VILLENEUVE, PhD, Contact, +33478 864 536, [email protected]