Clinical trial · Observational
Multicenter Observational Study Taulí-T1 Classification for the Management of pT1 Rectal Adenocarcinoma
Multicenter Observational Study on the Taulí-T1 Classification for Staging, Prognosis, and Management of pT1 Rectal Adenocarcinoma (TAUTEM-pT1 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)
BACKGROUND: Rectal cancer is the sixth most common neoplasm in Spain. In the early stages (pT1-N0), the treatment of choice is transanal endoscopic microsurgery. Treatment may be expanded to radical surgery if there are poor prognostic factors for the presence of metastatic lymph nodes and a risk of recurrence (up to 29%). The most determining histopathological factor is the degree of submucosal invasion. There are different classical classifications to assess this invasion, which pose difficulties in establishing objective and reproducible measurements. Casalots et al. propose a new classification (Taulí-T1) based on the measurement of residual healthy submucosa (hrSB), hypothesizing that a greater amount of healthy submucosa correlates with a better prognosis. Results show less healthy submucosa in the recurrence group, with a trend towards statistical significance (p=0.09). OBJECTIVE: To compare the Taulí-T1 classification with conventional quantitative classifications (Kitajima, Ueno) and qualitative classifications (sm1, sm2, and sm3 by Kudo and Kikuchi). METHODOLOGY: A multicenter observational retrospective cohort study comparing the Taulí-T1 classification with classical classifications in 317 patients with stage pT1 rectal adenocarcinoma, following the STROBE guidelines. The main variable is the measurement of tumor invasion in µm through hrSB, compared to the invasion of quantitative (Kitajima and Ueno) and qualitative (Kudo and Kikuchi) classical classifications. Concordance will be assessed with the intraclass correlation coefficient for quantitative variables and Cohen's weighted kappa for qualitative variables, with a 95% confidence interval and p\<0.005.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer Stage I | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Taulí-T1 versus conventional classifications | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Taulí-T1 versus conventional classifications
- timeFrame
- 30 days
- description
- Compare the Taulí-T1 classification versus the conventional quantitative methods (Kitajima, Ueno) and qualitative ones (sm1, sm2 and sm3 of Kudo and Kikuchi), to classify the stage pT1 rectal adenocarcinomas.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Rectal adenocarcinoma. * Histopathologically diagnosed with stage pT1. * Patients treated with transanal endoscopic surgery technique (TME, TEO or TAMIS). * Patients who have received prior neoadjuvant treatment (radiotherapy and/or chemotherapy). * Over 18 years. Exclusion Criteria: * Patients treated with other surgical techniques other than transanal endoscopic surgery. * Tumors other than adenocarcinoma. * Locations other than rectum.
References
Publications (2)
- BACKGROUNDCasalots A, Serra-Aracil X, Mora-Lopez L, Garcia-Nalda A, Pericay C, Ferreres JC, Navarro-Soto S. T1 Rectal Adenocarcinoma: a Different Way to Measure Tumoral Invasion Based on the Healthy Residual Submucosa with Its Prognosis and Therapeutic Implications. J Gastrointest Surg. 2021 Oct;25(10):2660-2667. doi: 10.1007/s11605-021-04948-9. Epub 2021 Feb 24. PMID 33629231
- DERIVEDGener-Jorge C, Ferreres Pinas JC, Moreno Garcia AB, Melgar Rivera DS, Casalots A, Nonell A, Espina B, Caro-Tarrago A, Serra-Aracil X. Interobserver agreement of the Tauli-pT1 classification in rectal pT1 adenocarcinoma. Int J Colorectal Dis. 2025 Sep 17;40(1):201. doi: 10.1007/s00384-025-04996-6. PMID 40957973