Clinical trial · Observational
Splicing-based Predictive Learning for Individual Chemotherapy Evaluation in Colorectal Cancer
Splicing-Based Predictive Learning for Individual Chemotherapy Evaluation in Colorectal Cancer (SPLICE)
NCT07226115CI-TRIAL-00117155SPLICErecruitingClinicalTrials.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)
Colorectal cancer (CRC) remains one of the leading causes of cancer-related mortality worldwide. Although adjuvant chemotherapy improves survival after curative resection, its efficacy varies widely among patients. The absence of reliable predictive biomarkers often leads to overtreatment or undertreatment. This study aims to develop a machine learning-based predictive model for adjuvant chemotherapy response using tumor-derived alternative splicing signatures. By integrating RNA-seq data, splicing isoform and clinical outcomes, this study seeks to identify molecular predictors of treatment response and recurrence risk after surgery.
Conditions
Conditions (4)
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 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 |
|---|---|---|---|
| SPLICE | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Non-responders of colorectal cancer (Training Cohort)
- description
- Non-responders of colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the first cohort
- interventionNames
- Other: SPLICE
- label
- Responders of colorectal cancer (Training Cohort)
- description
- Responders of colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the first cohort
- interventionNames
- Other: SPLICE
- label
- Non-responders of colorectal cancer, with recurrent disease (Validation Cohort)
- description
- Non-responders of 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
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage II-III colorectal cancer (TNM classification, 8th edition) * Received standard adjuvant chemotherapy after curative resection * Availability of tumor tissue (FFPE or frozen) before chemotherapy * Sufficient clinical data for outcome analysis (recurrence, survival) * Age 18-80 years Stage Exclusion Criteria: * Inflammatory bowel disease * Inadequate RNA quality or lack of consent
References
Publications (10)
- BACKGROUNDDienstmann R, Salazar R, Tabernero J. Personalizing colon cancer adjuvant therapy: selecting optimal treatments for individual patients. J Clin Oncol. 2015 Jun 1;33(16):1787-96. doi: 10.1200/JCO.2014.60.0213. Epub 2015 Apr 27. PMID 25918287
- BACKGROUNDDi Narzo AF, Tejpar S, Rossi S, Yan P, Popovici V, Wirapati P, Budinska E, Xie T, Estrella H, Pavlicek A, Mao M, Martin E, Scott W, Bosman FT, Roth A, Delorenzi M. Test of four colon cancer risk-scores in formalin fixed paraffin embedded microarray gene expression data. J Natl Cancer Inst. 2014 Sep 22;106(10):dju247. doi: 10.1093/jnci/dju247. Print 2014 Oct. PMID 25246611
- BACKGROUNDAuclin E, Zaanan A, Vernerey D, Douard R, Gallois C, Laurent-Puig P, Bonnetain F, Taieb J. Subgroups and prognostication in stage III colon cancer: future perspectives for adjuvant therapy. Ann Oncol. 2017 May 1;28(5):958-968. doi: 10.1093/annonc/mdx030. PMID 28453690
- BACKGROUNDAndre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18. PMID 19451431
- BACKGROUNDAndre T, Meyerhardt J, Iveson T, Sobrero A, Yoshino T, Souglakos I, Grothey A, Niedzwiecki D, Saunders M, Labianca R, Yamanaka T, Boukovinas I, Vernerey D, Meyers J, Harkin A, Torri V, Oki E, Georgoulias V, Taieb J, Shields A, Shi Q. Effect of duration of adjuvant chemotherapy for patients with stage III colon cancer (IDEA collaboration): final results from a prospective, pooled analysis of six randomised, phase 3 trials. Lancet Oncol. 2020 Dec;21(12):1620-1629. doi: 10.1016/S1470-2045(20)30527-1. PMID 33271092
- BACKGROUNDOkuno K, Kandimalla R, Mendiola M, Balaguer F, Bujanda L, Fernandez-Martos C, Aparicio J, Feliu J, Tokunaga M, Kinugasa Y, Maurel J, Goel A. A microRNA signature for risk-stratification and response prediction to FOLFOX-based adjuvant therapy in stage II and III colorectal cancer. Mol Cancer. 2023 Jan 20;22(1):13. doi: 10.1186/s12943-022-01699-2. No abstract available.