Colon CancerMARBLENCT07673393
Improving Prognostication in Colon Cancer
An observational study of Colon Cancer and Colon Adenocarcinoma, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colon Adenocarcinoma
- What is being tested?
- Blood draw for the laboratory assessment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2033
- Phase
- Observational
- 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
Study population: 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.
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Male and female participants, at least 18 years of age at the time of signing the Informed Consent Form (ICF).
- Newly diagnosed primary colon tumor clinically and/or histologically consistent with localized colon adenocarcinoma and planned for curative-intent surgical resection.
- Clinical stage compatible with non-metastatic disease at time of screening and considered eligible for standard curative-intent management according to investigator assessment.
- WHO (ECOG) performance status ≤ 3 at baseline.
Who cannot join
- Participant has been diagnosed with metastatic disease (Stage IV)
- Participant has been diagnosed with rectal cancer
- Participant has been diagnosed with synchronous primary colon tumors (i.e., presence of two or more primary colon tumors detected simultaneously at diagnosis)
- Participant has received prior systemic therapy (chemotherapy, targeted therapy, immunotherapy, or radiotherapy) for colon cancer
- Participation in an interventional Study with an investigational medicinal product (IMP) or device within 30 days prior to inclusion.
- Participant had prior history of colon cancer requiring systemic treatment or major colorectal oncologic surgery.
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Colon Cancer, Colon Adenocarcinoma
- Being tested
- Blood draw for the laboratory assessment
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for the laboratory assessmentOther
Study-specific blood samples for ctDNA analysis are collected between three and eleven times per participant, performed exclusively during routine standard-of-care venipunctures to ensure minimal risk and burden.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recurrence (TTR)
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.
Measured: Up to 5 years (the maximum follow-up period for recurrence and survival from the date of surgery or end of adjuvant chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2033 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673393
- Sponsor's protocol ID
- S72061
- Acronym
- MARBLE
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Prognostication of Localised Colon Cancer by Combining Liquid Biopsy and Histology: a Multicentric, Prospective Study
- ClinicalTrials.gov ID
- NCT07673393
- Acronym / sponsor ID
- MARBLE / S72061
- Conditions
- Colon Cancer, Colon Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2033 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 29 Jun 2026 (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.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Male and female participants, at least 18 years of age at the time of signing the Informed Consent Form (ICF).
- Newly diagnosed primary colon tumor clinically and/or histologically consistent with localized colon adenocarcinoma and planned for curative-intent surgical resection.
- Clinical stage compatible with non-metastatic disease at time of screening and considered eligible for standard curative-intent management according to investigator assessment.
- WHO (ECOG) performance status ≤ 3 at baseline.
Key exclusion criteria (7 listed)
- Participant has been diagnosed with metastatic disease (Stage IV)
- Participant has been diagnosed with rectal cancer
- Participant has been diagnosed with synchronous primary colon tumors (i.e., presence of two or more primary colon tumors detected simultaneously at diagnosis)
- Participant has received prior systemic therapy (chemotherapy, targeted therapy, immunotherapy, or radiotherapy) for colon cancer
- Participation in an interventional Study with an investigational medicinal product (IMP) or device within 30 days prior to inclusion.
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 draw for the laboratory assessmentStudy-specific blood samples for ctDNA analysis are collected between three and eleven times per participant, performed exclusively during routine standard-of-care venipunctures to ensure minimal risk and burden. | Other | – |
Primary outcome
Time to Recurrence (TTR)
Time frame: 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.
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 29 Jun 2026.
- Individual participant dataSharing planned: No. 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
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Colon Adenocarcinoma, run by Universitaire Ziekenhuizen KU Leuven.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Gertjan Rasschaert, Medical doctor (+32 16 34 37 91, gertjan.rasschaert@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Recurrence (TTR) (time frame: Up to 5 years (the maximum follow-up period for recurrence and survival from the date of surgery or end of adjuvant chemotherapy)). 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 29 Jun 2026.