Clinical trial · Observational
Predicting Local and Distant Recurrence in T1 Colorectal Cancer
Predicting Recurrence After Curative-Intent Resection of T1 Colorectal Cancer With Transcriptomics
NCT06314971CI-TRIAL-00091698T1CRcompletedClinicalTrials.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)
Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC. This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC.
Conditions
Conditions (6)
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms Malignant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tw1CE | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- T1 Colorectal Cancer, With Recurrence (Training)
- description
- Survivors of T1 colorectal cancer who developed recurrent colorectal cancer within 36 months from primary tumor treatment, in the first cohort
- interventionNames
- Other: Tw1CE
- label
- T1 Colorectal Cancer, Without Recurrence (Training)
- description
- Survivors of T1 colorectal cancer who did not develop recurrent colorectal cancer within 36 months from primary tumor treatment, in the first cohort
- interventionNames
- Other: Tw1CE
- label
- T1 Colorectal Cancer, With Recurrence (Validation)
- description
- Survivors of T1 colorectal cancer who developed recurrent colorectal cancer within 36 months from primary tumor treatment, in the second cohort
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage I, pT1 colorectal cancer (TNM classification, 8th edition). * Received standard diagnostic, staging, and stage-specific curative-intent resection (endoscopic or surgical, as per local guidelines). * Confirmed cancer-free survivorship at the time of study inclusion. Exclusion Criteria: * Lack of informed consent. * Induction of neoadjuvant systemic therapy before colorectal cancer resection. * Synchronous colorectal and non-colorectal cancer diagnosed at or before surgery.
References
Publications (29)
- BACKGROUNDAbdelmaksoud-Dammak R, Chamtouri N, Triki M, Saadallah-Kallel A, Ayadi W, Charfi S, Khabir A, Ayadi L, Sallemi-Boudawara T, Mokdad-Gargouri R. Overexpression of miR-10b in colorectal cancer patients: Correlation with TWIST-1 and E-cadherin expression. Tumour Biol. 2017 Mar;39(3):1010428317695916. doi: 10.1177/1010428317695916. PMID 28345456
- 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
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDChiu HM, Chen SL, Yen AM, Chiu SY, Fann JC, Lee YC, Pan SL, Wu MS, Liao CS, Chen HH, Koong SL, Chiou ST. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer. 2015 Sep 15;121(18):3221-9. doi: 10.1002/cncr.29462. Epub 2015 May 20. PMID 25995082
- BACKGROUNDDekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0. PMID 31631858
- BACKGROUNDJayanna M, Burgess NG, Singh R, Hourigan LF, Brown GJ, Zanati SA, Moss A, Lim J, Sonson R, Williams SJ, Bourke MJ. Cost Analysis of Endoscopic Mucosal Resection vs Surgery for Large Laterally Spreading Colorectal Lesions. Clin Gastroenterol Hepatol. 2016 Feb;14(2):271-8.e1-2. doi: 10.1016/j.cgh.2015.08.037. Epub 2015 Sep 11. PMID 26364679
- BACKGROUNDWeinberg RA. Mechanisms of malignant progression. Carcinogenesis. 2008 Jun;29(6):1092-5. doi: 10.1093/carcin/bgn104. Epub 2008 May 2. No abstract available.