Improving Prognostication in Colon Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood draw for the laboratory assessment
Other interventionStudy-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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: