Clinical trial · Observational
Early-Onset Colorectal Cancer Recurrence
Predicting Long-Term Recurrence-Free and Overall Survival in Early-Onset Colorectal Cancer Survivors
NCT06271980CI-TRIAL-00074919ENCOREcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance. This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid)
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Recurrent | — | UNRESOLVED | — |
| Colorectal Cancer Stage I | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Stage II | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Stage III | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ENCORE | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Survivors of early-onset colorectal cancer, with recurrent disease (Training Cohort)
- description
- Survivors of early-onset colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the first cohort
- interventionNames
- Other: ENCORE
- label
- Survivors of early-onset colorectal cancer, with no recurrent disease (Training Cohort)
- description
- Survivors of early-onset colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the first cohort
- interventionNames
- Other: ENCORE
- label
- Survivors of early-onset colorectal cancer, with recurrent disease (Validation Cohort)
- description
- Survivors of early-onset colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Stage I, II, or III colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50 * Received standard diagnostic, staging, and therapeutic procedures as per local guidelines, received stage-specific curative-intent resection (with or without systemic therapy, as appropriate) * Confirmed cancer-free survivors at the time of study inclusion Exclusion Criteria: * Hereditary colorectal cancer syndromes (identified through genetic testing) * Inflammatory bowel diseases * Lack of written informed consent
References
Publications (19)
- BACKGROUNDSinicrope FA. Increasing Incidence of Early-Onset Colorectal Cancer. N Engl J Med. 2022 Apr 21;386(16):1547-1558. doi: 10.1056/NEJMra2200869. No abstract available. PMID 35443109
- BACKGROUNDSiegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1. PMID 36856579
- BACKGROUNDSiegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17. PMID 38230766
- BACKGROUNDKim TJ, Kim ER, Hong SN, Chang DK, Kim YH. Long-Term Outcome and Prognostic Factors of Sporadic Colorectal Cancer in Young Patients: A Large Institutional-Based Retrospective Study. Medicine (Baltimore). 2016 May;95(19):e3641. doi: 10.1097/MD.0000000000003641. PMID 27175682
- BACKGROUNDYou YN, Dozois EJ, Boardman LA, Aakre J, Huebner M, Larson DW. Young-onset rectal cancer: presentation, pattern of care and long-term oncologic outcomes compared to a matched older-onset cohort. Ann Surg Oncol. 2011 Sep;18(9):2469-76. doi: 10.1245/s10434-011-1674-7. Epub 2011 Mar 30. PMID 21448750
- BACKGROUNDFoppa C, Tamburello S, Maroli A, Carvello M, Poliani L, Laghi L, Malesci A, Montorsi M, Perea J, Spinelli A. Early age of onset is an independent predictor for worse disease-free survival in sporadic rectal cancer patients. A comparative analysis of 980 consecutive patients. Eur J Surg Oncol. 2022 Apr;48(4):857-863. doi: 10.1016/j.ejso.2021.10.021. Epub 2021 Oct 28. PMID 34740480
- BACKGROUNDKim SB, Lee HJ, Park SJ, Hong SP, Cheon JH, Kim WH, Kim TI. Comparison of Colonoscopy Surveillance Outcomes Between Young and Older Colorectal Cancer Patients. J Cancer Prev. 2017 Sep;22(3):159-165. doi: 10.15430/JCP.2017.22.3.159. Epub 2017 Sep 30.