Clinical trial · Observational
Improving Prognostication in Colon Cancer
Improving Prognostication of Localised Colon Cancer by Combining Liquid Biopsy and Histology: a Multicentric, Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenocarcinoma | Colon Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw for the laboratory assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to Recurrence (TTR)
- timeFrame
- Up to 5 years (the maximum follow-up period for recurrence and survival from the date of surgery or end of adjuvant chemotherapy)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available