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Improving Prognostication in Colon Cancer (MARBLE)

22 juin 2026 mis à jour par: Universitaire Ziekenhuizen KU Leuven

Improving Prognostication of Localised Colon Cancer by Combining Liquid Biopsy and Histology: a Multicentric, Prospective Study

The goal of this study is to test better ways to predict if cancer will return after surgery in adults (18+) who have been diagnosed with stage II or III colon cancer.

The main questions it aims to answer are:

  • Can computer programs (Artificial Intelligence) and special blood tests give more accurate information about the risk of cancer returning than the methods doctors use today?
  • Does combining these new tests help doctors better understand which patients really need chemotherapy and which do not?

Researchers will compare the new computer and blood tests to the standard hospital methods used now to see if the new way is more accurate in predicting the cancer's behavior

Participants will:

  • Sign a form saying they agree to take part in the study
  • Have their standard surgery to remove the tumor
  • Give a few extra teaspoons of blood during their regular, scheduled hospital visits
  • Allow researchers to scan and study a small piece of the tumor that was already removed during surgery
  • Continue with their normal hospital check-ups for up to five years so researchers can track their health

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

The MARBLE study is a prospective, multicentric, single-arm exploratory trial designed to integrate novel tissue- and blood-based prognostic modalities to improve risk stratification for patients with Stage II and III colon cancer. The study evaluates three primary prognostic modalities:

  • Pathological Tumor-Node-Metastasis (pTNM) staging
  • Machine Learning (ML) Histopathology: A validated graph neural network model analyzes digitized hematoxylin and eosin (H&E) stained slides to generate survival predictions and predict regional gene expression independent of pTNM stage
  • Multi-modal ctDNA Assay: An in-house circulating tumor DNA (ctDNA) assay that moves beyond mutation detection by profiling epigenomic markers and genome-wide fragmentomic patterns in cell-free DNA (cfDNA) to enhance sensitivity for minimal residual disease (MRD).

Study Design and Workflow Participants are stratified post-surgery into four treatment-related groups (A-D) that reflect real-world standard-of-care (SoC) pathways rather than randomized arms:

  • Group A: Low-risk Stage II (no adjuvant chemotherapy).
  • Group B/C: Intermediate to high-risk Stage II/III (3-6 months of adjuvant chemotherapy).
  • Group D: High-risk Stage III (6 months of chemotherapy), featuring intensified longitudinal sampling every 6 months for 36 months post-treatment to capture MRD dynamics.

Statistical Approach The primary analysis involves comparing mono-modal and multi-modal risk models to evaluate their prognostic performance for Time to Recurrence (TTR).

Technical evaluation will utilize Cox proportional hazards models, assessing discrimination via ΔC-index, model fit through likelihood ratio testing, and clinical utility using Net Reclassification Improvement (NRI). The study also quantifies the lead time between molecular (ctDNA) and radiological recurrence.

Type d'étude

Observationnel

Inscription (Estimé)

400

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The MARBLE study focuses on a target population of approximately 400 adult participants with pathologically confirmed Stage II or III colon cancer. To achieve this enrollment, the study plans to screen up to 500 patients who are receiving standard-of-care surgical treatment for suspected localized colon cancer.

La description

Inclusion Criteria:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
  2. Male and female participants, at least 18 years of age at the time of signing the Informed Consent Form (ICF).
  3. Newly diagnosed primary colon tumor clinically and/or histologically consistent with localized colon adenocarcinoma and planned for curative-intent surgical resection.
  4. Clinical stage compatible with non-metastatic disease at time of screening and considered eligible for standard curative-intent management according to investigator assessment.
  5. WHO (ECOG) performance status ≤ 3 at baseline.

Exclusion Criteria:

  1. Participant has been diagnosed with metastatic disease (Stage IV)
  2. Participant has been diagnosed with rectal cancer
  3. Participant has been diagnosed with synchronous primary colon tumors (i.e., presence of two or more primary colon tumors detected simultaneously at diagnosis)
  4. Participant has received prior systemic therapy (chemotherapy, targeted therapy, immunotherapy, or radiotherapy) for colon cancer
  5. Participation in an interventional Study with an investigational medicinal product (IMP) or device within 30 days prior to inclusion.
  6. Participant had prior history of colon cancer requiring systemic treatment or major colorectal oncologic surgery.
  7. Any severe, uncontrolled, or life-threatening medical condition that, in the opinion of the investigator, could interfere with study participation, interpretation of study assessments, or pose excessive risk to the participant (e.g. severe cardiac, hepatic, renal, or uncontrolled infectious disease).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time to Recurrence (TTR)
Délai: Up to 5 years (the maximum follow-up period for recurrence and survival from the date of surgery or end of adjuvant chemotherapy)
The primary outcome measure for the MARBLE study is Time to Recurrence (TTR). This variable is defined as the time interval from the date of curative-intent surgery to the date of the first documented colon cancer recurrence, whether local or distant.
Up to 5 years (the maximum follow-up period for recurrence and survival from the date of surgery or end of adjuvant chemotherapy)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universitaire Ziekenhuizen KU Leuven

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2033

Achèvement de l'étude (Estimé)

1 septembre 2033

Dates d'inscription aux études

Première soumission

22 juin 2026

Première soumission répondant aux critères de contrôle qualité

22 juin 2026

Première publication (Réel)

29 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • S72061

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

There are currently no plans to share de-identified individual participant data with the general public. This is to ensure the strict protection of participant confidentiality and the security of personal health information as required by the General Data Protection Regulation (GDPR) and Belgian law

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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