Clinical trial · Observational
Stage II/III Colorectal Cancer Recurrence
Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment
NCT06314958CI-TRIAL-00117137CENSURErecruitingClinicalTrials.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)
This study will develop an assay to predict disease recurrence in patients with stage II/III CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation.
Conditions
Conditions (5)
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 | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Colorectal Cancer Stage II | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Stage III | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CENSURE | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Stage II/III Colorectal Cancer, with Recurrence (Training)
- description
- Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.
- interventionNames
- Other: CENSURE
- label
- Stage II/III Colorectal Cancer, without Recurrence (Training)
- description
- Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and did not experience recurrence within five years.
- interventionNames
- Other: CENSURE
- label
- Stage II/III Colorectal Cancer, with Recurrence (Validation)
- description
- Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage II (high-risk) or III colorectal cancer (TNM classification, 8th edition). * Received standard diagnostic, staging, and therapeutic procedures as per local guidelines * Received stage-specific curative-intent resection followed by adjuvant chemotherapy. * Confirmed cancer-free survivorship confirmed at the time of study inclusion. Exclusion Criteria: * Lack of written informed consent. * Development of recurrence in the first 6 months following adjuvant chemotherapy completion. * Hereditary colorectal cancer syndromes (identified through genetic testing) * Inflammatory bowel diseases
References
Publications (19)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDSiegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. PMID 36633525
- BACKGROUNDFrei AL, McGuigan A, Sinha RRAK, Jabbar F, Gneo L, Tomasevic T, Harkin A, Iveson T, Saunders MP, Oien KA, Maka N, Pezzella F, Campo L, Browne M, Glaire M, Kildal W, Danielsen HE, Hay J, Edwards J, Sansom O, Kelly C, Tomlinson I, Kerr R, Kerr D, Domingo E; TransSCOT consortium; Church DN, Koelzer VH. Multiplex analysis of intratumoural immune infiltrate and prognosis in patients with stage II-III colorectal cancer from the SCOT and QUASAR 2 trials: a retrospective analysis. Lancet Oncol. 2024 Feb;25(2):198-211. doi: 10.1016/S1470-2045(23)00560-0. PMID 38301689
- BACKGROUNDArgiles G, Tabernero J, Labianca R, Hochhauser D, Salazar R, Iveson T, Laurent-Puig P, Quirke P, Yoshino T, Taieb J, Martinelli E, Arnold D; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Localised colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1291-1305. doi: 10.1016/j.annonc.2020.06.022. Epub 2020 Jul 20. No abstract available. PMID 32702383
- BACKGROUNDLiu Z, Guo C, Dang Q, Wang L, Liu L, Weng S, Xu H, Lu T, Sun Z, Han X. Integrative analysis from multi-center studies identities a consensus machine learning-derived lncRNA signature for stage II/III colorectal cancer. EBioMedicine. 2022 Jan;75:103750. doi: 10.1016/j.ebiom.2021.103750. Epub 2021 Dec 15. PMID 34922323
- BACKGROUNDFeng Q, Chang W, Mao Y, He G, Zheng P, Tang W, Wei Y, Ren L, Zhu D, Ji M, Tu Y, Qin X, Xu J. Tumor-associated Macrophages as Prognostic and Predictive Biomarkers for Postoperative Adjuvant Chemotherapy in Patients with Stage II Colon Cancer. Clin Cancer Res. 2019 Jul 1;25(13):3896-3907. doi: 10.1158/1078-0432.CCR-18-2076. Epub 2019 Apr 15.