Improving Prognostication in Colon Cancer

NCT07673393 | Not Yet Recruiting

• 1 other identifier: S72061
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Conditions

Colon Cancer; Colon Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 5 years (the maximum follow-up period for recurrence and survival from the date of surgery or end of adjuvant chemotherapy)

Interventions

Blood draw for the laboratory assessment OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood-derived Samples for ctDNA: The study retains the remainders of blood samples and extracted cell-free DNA (cfDNA)

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Gertjan Rasschaert, Medical doctor

CONTACT

+32 16 34 37 91; gertjan.rasschaert@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2033
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share